Conditions: Physical Activity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: yes

Brief summary:
Exercise is frequently prescribed as a favorable lifestyle intervention to prevent/reverse type 2 diabetes. It is also prescribed in addition to concurrent pharmacological treatment, such as metformin. Recent data (animal and human) suggest that metformin may attenuate the favorable benefits of exercise training. In light of the physiological mechanism of Dapagliflozin (sodium-glucose co-transporter 2 (SGLT2) inhibition), one might speculate that rather than inhibit, it will augment the favorable adaptations to exercise training.

Detailed description:
This is a randomized, placebo-controlled, double blind, repeated measures study. 30 sedentary adults will be recruited for participation and randomly assigned to one of two 12-week treatments: 1) supervised endurance exercise training 4 days per week plus daily oral administration of Dapagliflozin; 2) supervised endurance exercise training 4 days per week plus daily oral administration of placebo. Prior to and following completion of the treatment the following dependent variables will be quantified: a) maximal aerobic capacity; b) substrate utilization during standardized low-moderate intensity exercise; c) skeletal muscle aerobic enzyme activity; d) body composition; and, e) oral glucose tolerance, fasting glucose and insulin resistance.

The dose of Dapagliflozin will begin as 5 mg/day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to 10 mg/day for the remainder of the study.

Arms:
arm 1: The dose of Dapagliflozin will begin as one 5 mg tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two 5 mg tablets per day for the remainder of the study. arm 2: Matching placebo for Dapagliflozin 5 mg will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.

Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days. intervention 2: Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.

Protocol document:
Prot_SAP_ICF_000.pdf: 
 
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Continuing review
1
Personnel Information
3
Subject Population
5
Study Location
5
General Checklist
6
Funding
8
Expedited Paragraphs
9
Purpose,Study Procedures,Background
11
Radioisotopes or Radiation Machines
18
Medical Equipment for Human Subjects and Laboratory Animals; Investigatiional Devices
19
Drugs, Reagents, or Chemicals
19
Subject Population (a-g)
20
Subject Population (h-m)
23
Risks
25
Benefits, Procedures to Maintain Confidentiality
31
Potential Conflict of Interest
31
Informed Consent
32
Assent Background
33
HIPAA
33
Attachments
35
Obligations
40


 
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Event History
41


Page 1 of 47
 
1
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
* * * Continuing review * * *
 
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Page 2 of 47
 
2
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 3 of 47
 
3
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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* * * Personnel Information * * *
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Page 4 of 47
 
4
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 5 of 47
 
5
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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* * * Subject Population * * *
 
 
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Page 6 of 47
 
6
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
 
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Page 7 of 47
 
7
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 8 of 47
 
8
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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* * * Funding * * *
 
Please complete this section if:  1. This protocol will be funded, 2. You have submitted or will submit a grant
application associated with this protocol.  Please be sure to input your PASS/SP1 number to assist Sponsored
Programs in setting up an account for your funds.
If this protocol is funded by the NIH or NSF, or will lead to the regulatory involvement of the FDA or EPA, please
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Page 9 of 47
 
9
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
Funding - Other
 
Gift Funding
Dept. Funding
Other Funding
---------------------------------------------------------------------------------------------
* * * Expedited Paragraphs * * *
 
PLEASE READ:  This online application is for projects that will be reviewed by the IRB via the expedite or full-
board review process.  The criteria for expedited review are listed below. Review and check what expedite
criteria is/are appropriate for your project. NOTE:  If your research involves or may involve greater than minimal
risk, an element of deception, or is FDA-regulated research, do NOT check any of the expedited criteria listed
below.  Your protocol will then be reviewed by the full-board at their next regularly scheduled meeting.  If your
project meets the exempt criteria, please submit your exempt application via email to:
RICRO_IRB@mail.colostate.edu.  Information regarding exempt applications can be found here:
http://ricro.colostate.edu/IRB/ExemptReview.html
 
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Page 10 of 47
 
10
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
 
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Page 11 of 47
 
11
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
 
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* * * Purpose,Study Procedures,Background * * *
 
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Page 12 of 47
12
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 13 of 47
13
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 14 of 47
14
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 15 of 47
15
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
 
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Page 16 of 47
16
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 17 of 47
17
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 18 of 47
18
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 19 of 47
19
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 20 of 47
20
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
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Page 21 of 47
21
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 22 of 47
22
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 23 of 47
23
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 24 of 47
24
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 25 of 47
25
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
 
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Page 26 of 47
26
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 27 of 47
27
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 28 of 47
28
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 29 of 47
29
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
 
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Page 30 of 47
30
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 31 of 47
31
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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* * * Benefits, Procedures to Maintain Confidentiality * * *
 
 
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* * * Potential Conflict of Interest * * *


Page 32 of 47
32
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
 
 
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* * * Informed Consent * * *
 
 
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Page 33 of 47
33
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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* * * Assent Background * * *
 
 
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---------------------------------------------------------------------------------------------


Page 34 of 47
34
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
* * * HIPAA * * *
 
 
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guidelines. If your project will involve a HIPAA-regulated entity, in the Attachment section (#16) please attach that
entity's required HIPAA consent and/or each waiver of authorization or alteration of authorization requested (e.g.,
waiver of authorization for access to medical records). Include HIPAA authorization language in the consent
document(s) as appropriate (e.g., when enrolling subjects).  
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Page 35 of 47
35
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------

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---------------------------------------------------------------------------------------------
* * * Attachments * * *
 
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Page 36 of 47
36
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 37 of 47
37
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 38 of 47
38
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 39 of 47
39
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 40 of 47
40
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
'RFXPHQW7\SH
2WKHU3URWRFRO0DWHULDO
$WWDFKPHQW
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---------------------------------------------------------------------------------------------
* * * Obligations * * *
 
 
Obligations (Researcher's Responsibilities)
 
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Page 41 of 47
41
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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7UDLQLQJ&RPSOHWHG"
 
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ZHOIDUHWRKXPDQVXEMHFWVWKLVPXVWEHUHSRUWHGWRWKH,5%ZLWKLQKRXUV
 
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---------------------------------------------------------------------------------------------
* * * Event History * * *
Event History
Date
Status
View Attachments
Letters
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Page 42 of 47
42
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 43 of 47
43
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 44 of 47
44
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 45 of 47
45
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Page 46 of 47
46
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
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Page 47 of 47
47
PROTOCOL
Biomedical
Protocol # 14-5529H
 Date Printed: 01/30/2019
Protocol Title:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise Training?
Clinical Research Protocol Title: Dapagliflozin  Augments The Favorable Adaptation To
Endurance Exercise Training
Protocol Type:
Biomedical
Date Submitted:
11/01/2018
Approval Period:
11/06/2018-11/05/2019
Important Note:
This Print View may not reflect all comments and contingencies for approval. Please check the
comments section of the online protocol.
Questions that appear to not have been answered may not have been required for this submission.
Please see the system application for more details.
----------------------------------------------------------------------------------------------------
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Methods of statistical analyses
Two-way analysis of variance (before training vs. after training, and Dapagliflozin vs. Placebo) 
with repeated measures on one factor (before vs. after) are used to examine differences in 
primary outcomes resulting from exercise training and/or drug treatment.  Multiple comparisons 
of factor means will be performed using the Newman-Keuls test.


Page 1 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
Consent to Participate in a Research Study
Colorado State University
TITLE OF STUDY:
Does Dapagliflozin Augment The Favorable Adaptation To Endurance Exercise 
Training?
CO-PRINCIPAL INVESTIGATORS:
Christopher Bell, Ph.D.
Christopher L. Melby, Dr.P.H.
Health & Exercise Science
Food Science & Human Nutrition
Colorado State University
Colorado State University
Email: physiology@cahs.colostate.edu
Email: chris.melby@colostate.edu
Telephone: 970-491-3495
Telephone: 970-491-6736
WHY AM I BEING INVITED TO TAKE PART IN THIS RESEARCH?
You are aged between 18-50 years, your body mass index is between 25 and 45 kg/m2,
you are free of diabetes, you are not pregnant, and/or you are not a regular exerciser,
but would like to be.
WHO IS DOING THE STUDY? 
Drs. Bell and Melby are running the study; local medical doctors, other researchers, and 
a team of trained graduate and undergraduate students are helping. AstraZeneca 
Pharmaceuticals LP, a company that makes medicine, is providing financial support for 
the study.  
WHAT IS THE PURPOSE OF THIS STUDY? 
Dapagliflozin (commercially known as Farxiga; pronounced: far-see-gah) is a new 
medicine for treating type 2 diabetes.  The purpose of the study is to discover if taking 
Dapagliflozin will improve people’s response to regular exercise.  That is, if people 
perform regular exercise while using Dapagliflozin, will they become fitter and leaner 
than similar people who perform the same exercise but do not use Dapagliflozin?


Page 2 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?
The study will take place in the Human Performance/Clinical Research Laboratory
(HPCRL) and in the Health and Exercise Science Cardiovascular Training Room, both 
of which are located in the Department of Health and Exercise Science, Moby Complex,
on the main campus of Colorado State University, Fort Collins, Colorado.
The study will take place over approximately 2 years.  You will be involved for 
approximately 4 months and will be asked to visit the Human Performance Clinical 
Research Laboratory on 51 different days.
WHAT WILL I BE ASKED TO DO?
Here is a brief summary of what you will be asked to do:
You will report to the Human Performance Clinical Research Laboratory (HPCRL) on 51
separate days:
Visit 1: you will undergo screening: medical history, 12-lead electrocardiogram and 
blood pressure assessment at rest and during incremental exercise to volitional 
exhaustion, blood sampling, and measurement of body composition.
Visit 2: maximal oxygen uptake will be measured.
Visit 3: the metabolic response to standardized exercise will be determined.
Visit 4: an oral glucose tolerance test will be performed, and then skeletal muscle will be 
sampled.
Visits 5-48: 12 weeks of supervised exercise training.  Concurrent with these visits, you
will ingest, on a daily basis, either Dapagliflozin or placebo. 
Visit 49: maximal oxygen uptake and body composition will be measured.
Visit 50: the metabolic response to standardized exercise will be determined.
Visit 51: an oral glucose tolerance test will be performed, and then skeletal muscle will 
be sampled.


Page 3 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
Outline and timing of study visits:
Days -14 to -1
(Weeks -2 to 0)
Day 1
(Week 1) for 
12 weeks 
Days 85 to 91
(Week 13)
Screening
VO2max
Response to 
standardized 
exercise
OGTT
&
Biopsy
Initiation of 
treatment 
(Placebo or 
Dapagliflozin
plus 
exercise)
VO2max
Response to 
standardized 
exercise
OGTT
&
Biopsy
VO2max: Maximal oxygen uptake.  OGTT: Oral glucose tolerance test.  
Here is a detailed description of what you will be asked to do:
Visit 1 – Screening Visit / Medical History / Stress Test / Blood Test / Body 
Composition
The first visit to the Human Performance Clinical Research Lab (HPCRL) will be a 
screening visit.  During this visit we will make sure that participation in this study is right 
for you.
This screening visit will include the following procedures:
Medical Questionnaire
You will be asked to answer several pages of questions related to your health, any 
illness you may have or have had, and medications you use or have used in the past. 
Blood Pressure
We will measure your blood pressure using a standard blood pressure cuff (the same as 
in a doctor's office). Blood pressure will be measured during all of the tests performed in
the lab with the exception of body composition.  There are no known risks associated 
with this procedure. (Duration: 5 minutes)
Body Composition
We will measure how much fat you have in your body using a test called dual energy x-
ray absorptiometry (DEXA).  The DEXA test requires you to lie quietly on a padded 
table while a small probe gives off low-level x-rays and sends them over your entire 
body.  This test gives very accurate measurements of your body fat and bone mineral 
density.  We will also measure the circumference of your waist and hip using a tape 
measure. (Duration: ~ 15 minutes)
Pregnancy Test (Women Only)
Women who are or could be pregnant should not participate in this study.  Before the 
body composition test(s) women will be asked to use a pregnancy test (urine test) to 
confirm they are not pregnant.   


Page 4 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
Blood Test
During this visit we will be taking blood from you.  We will be taking approximately 20 ml 
(~1.5 table spoons); this is a lot less than the amount that is typically taken when a 
person donates blood. Your blood will be tested for various things to make sure you are 
healthy enough to consume Dapagliflozin.  Your blood will be taken from veins in your 
arms or hands using needles and hollow plastic tubes called catheters. As per the 
medical monitor’s discretion, you may be asked to have your blood tested periodically 
during the intervention period.
Exercise Stress Test
You will be asked to perform a vigorous exercise test.  This test will tell us if your heart 
is healthy.  You will be asked to walk on a motorized treadmill or ride an exercise cycle 
(cycle ergometer) for approximately 10-15 minutes. The exercise will become more 
difficult every 2 minutes.  While you are walking/riding we will measure your heart rate 
with an electrocardiogram (ECG) and your blood pressure with a cuff placed around 
your upper arm.  We will also ask you to wear a nose clip (something that stops you 
breathing through your nose) and ask you to breathe through a mouthpiece.  This will let 
us measure the gases you breathe. Depending on your age, a physician may supervise 
the test.  If we do not think your heart is healthy you will be referred to your primary care 
physician for further testing.  There is a chance that you may not be allowed to take part 
in our study. (Duration: ~ 60 minutes)
Visit 2 – Maximal Aerobic Capacity
You will be asked to perform a vigorous exercise test. You will be asked to ride an 
exercise cycle (cycle ergometer) for approximately 10-15 minutes. The exercise will 
become more difficult every 2 minutes.  You will be asked to exercise until you become 
so tired you are unable to push the pedals more than 40 revolutions per minute.  While 
you are riding we may measure your heart rate with an electrocardiogram (ECG) and 
your blood pressure with a cuff placed around your upper arm.  We will also ask you to 
wear a nose clip (something that stops you breathing through your nose) and ask you to 
breathe through a mouthpiece.  This will let us measure the gases you breathe. 
(Duration: ~ 60 minutes)
Visit 3 – Metabolic Response To Standardized Exercise
You will be asked to ride a stationary exercise bike for approximately 30 minutes.  For 
the first 10 minutes the intensity will be very, very light.  During the second 10 minutes 
the intensity will be increased but will still be moderate.  During the final 10 minutes the 
intensity will be increased again such that it is quite difficult, but still achievable.  
Throughout the entire ride we may measure your heart rate with an electrocardiogram 
(ECG) and your blood pressure with a cuff placed around your upper arm.  We will also 
ask you to wear a nose clip (something that stops you breathing through your nose) and 
ask you to breathe through a mouthpiece.  This will let us measure the gases you 
breathe.  You will only wear the mouthpiece during the final 5 minutes of each 10-
minute period.


Page 5 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
During this visit we will be taking blood from you.  We will be taking approximately 80 ml 
(~6 table spoons); this is a lot less than the amount that is typically taken when a person 
donates blood. Your blood will be tested for various things that are involved with your 
nerves, the amount of calories you burn at rest, and insulin and glucose (blood sugar).  
Your blood will be taken from veins in your arms or hands using needles and hollow 
plastic tubes called catheters.
You will be provided with additional food to eat prior to this visit.
Visit 4 – Oral Glucose Tolerance Test and Skeletal Muscle Sampling
You will be asked to drink water (300 ml or ~ 10 oz) in approximately 5 minutes.  A 
small amount of sugar (75 g of glucose) will have been added to the water.  This will 
make it taste sweeter and also increase your blood sugar.  
After drinking the water you will sit/lie quietly for 2 hours.  You will be able to read and/or 
watch TV and/or listen to music.  We will collect blood from you over the 2 hours.  Your 
blood will be analyzed for concentrations of sugar (glucose), insulin (something that 
helps control blood sugar), and other things that may be help control blood sugar. Your 
blood will be taken from veins in your arms or hands using needles and hollow plastic 
tubes called catheters.
We will then sample a small piece of your muscle.  This test is commonly called a 
muscle biopsy.  During the muscle biopsy a drug (an anesthetic) will be injected into an 
area of your thigh to make it feel numb.  A small incision (roughly 1/4 inch) will be made 
using a sharp sterile blade.  A sterile probe will be inserted into your leg and a little 
piece of muscle (roughly the size of a sweet corn kernel) will be removed.
The whole visit will last approximately 3 hours.
Visits 5 – 48 – Supervised Exercise Training
You will report to the Health and Exercise Science Cardiovascular Training Room on 44
separate occasions, spread out over 12-weeks, for supervised exercise training. 
Exercise will begin with 3 training sessions per week of 20-40 minutes, and progress 
after 4 weeks to 4 sessions per week of 40-60 minutes. The exercise will be difficult 
enough to increase your heart rate to 70-80% of your maximum measured heart rate
reserve. This will feel like moderate-to-difficult exercise, with a measured rate of 
perceived exertion (RPE) falling between 13-15. If an RPE indicative of moderate-to-
difficult exercise is not achieved by a heart rate at 70-80% of heart rate reserve, the 
exercise intensity will be adjusted to achieve an appropriate difficulty of exercise. The 
exercise will be treadmill walking/running, stationary cycle ergometer exercise (exercise 
bike), and elliptical ergometer exercise. The exercise will be varied between, but not 
within, sessions to avoid boredom and potential overuse injuries. In total, you will be 
scheduled to complete 44 exercise sessions. If you fail to complete 40 sessions (~90%), 


Page 6 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
or two sessions within a 7-day period you will be removed from the study. Every session 
will begin and end with a 5-minute self-paced warm-up/cool-down. These 5-minute 
periods will not be included in the training duration (for example, a 20 minute session 
will consist of a 5-minute warm-up, 20 minutes of exercise training, and 5 minutes of 
cool-down).
At the same time as Visits 5 – 48: Daily Ingestion of Dapagliflozin or Placebo
During the 12 weeks of exercise training you will swallow a pill every day.  The pill may 
be Dapagliflozin or a placebo, a pill that has no effect.  Neither you, nor the 
investigators, will know which pill you are swallowing. If you are chosen to swallow 
Dapagliflozin, for the first 2-weeks the dose will be 5 mg/day.  For the next 10-weeks the 
dose will be 10 mg/day. For a description of Dapagliflozin, see below.
Visit 49 – Maximal Aerobic Capacity and Body Composition
You will repeat the procedures described in visit 2.  You will also undergo measurement 
of body composition (as described in visit 1).
Visit 50 – Metabolic Response to Standardized Exercise
You will repeat the procedures described in visit 3.
Visit 51 – Oral Glucose Tolerance Test and Skeletal Muscle Sampling
You will repeat the procedures described in visit 4.
What is Dapagliflozin?
Dapagliflozin is a new medicine that is used to treat people who have type 2 diabetes 
(high blood sugar and/or difficulty controlling blood sugar). Dapagliflozin works by 
limiting the body’s ability to absorb sugar from food and beverages.  It does this by 
changing the ability of the kidneys to absorb sugar.  The sugar that is not absorbed is 
removed from the body in urine.
ARE THERE REASONS WHY I SHOULD NOT TAKE PART IN THIS STUDY?
You will not be allowed to take part in the study for any of the following reasons:
1. Evidence of serious (clinically significant) heart (cardiovascular), lung (respiratory),
kidney (renal), liver (hepatic), stomach (gastrointestinal), blood (hematological), nerve 
(neurological), mental (psychiatric), or other disease, or if you have been hospitalized in 
the past 2 years as a result of these conditions, or are receiving medicine 
(pharmacological treatment) for these conditions.


Page 7 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
2. Use of prescription drugs (see exceptions listed below) or herbal preparations in the 
4 weeks before study commencement.
Permitted Prescription Drugs
x
Birth Control 
x
Less than 7 days, short course antibiotics. Note: Rifampin is not permitted.
Other medicines, for GERD, depression, seasonal allergies and OTC analgesics, may be 
allowed, but will be approved on a case-by-case basis.
3. You are currently enrolled in another clinical study for another investigational drug or 
have taken any other investigational drug within 30 days before the screening visit.
4. You are a smoker: Habitual and/or recent use (within 2 years) of tobacco.
5. You are considered unsuitable for participation in this trial for any reason, as judged 
by the investigator or medical monitor.
6. You have a history of serious hypersensitivity reaction to Dapagliflozin.
7. You have severe kidney problems: renal impairment, end-stage renal disease, or 
dialysis.
8. You are pregnant or breastfeeding.
9. You have severe hepatic insufficiency and/or significant abnormal liver function 
based on blood tests.
10. You have a history of bladder cancer.
11. Your blood pressure during visit 1: 6\VWROLFEORRGSUHVVXUHPP+JDQGRU
GLDVWROLFEORRGSUHVVXUHPP+J
12. Your blood pressure before visit 56\VWROLFEORRGSUHVVXUHPP+JDQGRU
GLDVWROLFEORRGSUHVVXUHPP+J
13. Patients who, in the judgment of the medical doctor, may be at risk for dehydration.
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
It is not possible to identify all potential risks in research procedures, but the 
researcher(s) have taken reasonable safeguards to minimize any known and potential 
(but unknown) risks. The Human Performance Clinical Research Laboratory has 
emergency supplies including a medicine trolley equipped with heart machines and 
supplemental oxygen. The research team has a great deal of experience with all of the 
procedures.  Some of the procedures for which you are being asked to volunteer have a 
number of associated risks:


Page 8 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
Body Composition
The risks associated with the DEXA are very low.  The maximum radiation dose you will 
receive in this study is less than 1/1000th of the federal and state occupational whole 
body dose limit allowed to radiation workers (5,000 mrem).  Put another way, the 
maximum dose from any scan we utilize with this DEXA ranges from 1.2 mrem (Whole 
body scan) to 12.2 mrem (for several of the regional scans, such as lumbar, femur, and 
forearm scans).  The average annual background radiation you already receive is at 
least 620 mrem/year.  The more radiation you receive over the course of your life, the 
more the risk increases of developing a fatal cancer or inducing changes in genes.  The 
radiation in this scan is not expected to significantly increase these risks, but the exact 
increase in such risks is not known.  There are no discomforts associated with this 
procedure. Women who are or could be pregnant should receive no unnecessary 
radiation and should not participate in this study.
Exercise Tests and Exercise Training
There is a very small chance of an irregular heartbeat during exercise (< 1% of all 
subjects).  Other rare risks of a stress test are heart attack (< 5 in 10,000) and death (<2 
in 10,000).  Wearing a mouthpiece and nose-clip can sometimes cause dryness in the 
mouth and mild discomfort. Difficult exercise may make you feel very tired, light headed 
and nauseous.  Exhausting exercise will, by definition, make you feel very tired.  After 
any exercise your muscles might ache.
Blood Collection
When the needle goes into a vein, it may hurt for a short period of time (a few seconds).  
Also there may be minor discomfort of having the needle/plastic tube taped to your arm.  
In about 1 in 10 cases, a small amount of bleeding will occur under the skin that will 
cause a bruise.  The risk of forming a blood clot in the vein is about 1 in 100, and the 
risk of significant blood loss is 1 in 1,000.  Additionally, there is a risk that you may faint 
while having blood collected or having the catheter inserted in your vein.
Muscle Biopsy
During the procedure you may feel discomfort associated with the injection of the 
numbing drug (the anesthetic) but during the actual muscle removal the discomfort 
should be minimal. There is a risk that you may faint during the procedure. There is also 
a risk of muscle cramp, bleeding, of loss of feeling in your leg, and of damage to a skin 
(cutaneous) nerve.  The risk of infection and bruising is extremely small if you follow the 
instructions for caring for the incision.  A very small and minor scar will remain as a result 
of the incision, but may not be noticeable. These procedures will be performed under 
surgically clean conditions.  Emergency medical equipment will be available.  You will be 
screened prior to the procedure for history of allergic reactions to Novocain (Lidocaine).


Page 9 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
Dapagliflozin
Adverse reactions in placebo-controlled studies reported in more than 2% but less than 
8.5% of patients treated with Dapagliflozin include:
x
Female genital mycotic infections (fungal or yeast infections), such as (listed in 
order of frequency reported): vulvovaginal mycotic infection, vaginal infection, 
vulvovaginal candidiasis, vulvovaginitis, genital infection, genital candidiasis, 
fungal genital infection, vulvitis, genitourinary tract infection, vulval abscess, and 
vaginitis bacterial. 
x
Nasopharyngitis (cold-like symptoms)
x
Urinary tract infections, such as (listed in order of frequency reported): urinary 
tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract 
infection, pyelonephritis, trigonitis, urethritis, kidney infection, and prostatitis.
x
Back pain
x
Increased urination
x
Male genital mycotic infections (fungal or yeast infections), such as (listed in order 
of frequency reported): balanitis, fungal genital infection, balanitis candida, genital 
candidiasis, genital infection male, penile infection, balanoposthitis,
balanoposthitis infective, genital infection, and posthitis.
x
Influenza (Flu)
x
Nausea (Upset stomach)
x
Dyslipidemia (High Cholesterol)
x
Constipation
x
Discomfort with urination
x
Pain in extremity
In a study of 5,936 patients with type 2 diabetes, one patient became ill with diabetic 
ketoacidosis (a metabolic sickness).  If you experience any of the following 
sensations/symptoms you should seek immediate medical help and contact the 
investigator: sickly or queasy (nausea), vomiting, stomach (abdominal) pain, confusion, 
change in breathing pattern and unusual tiredness (fatigue) or sleepiness.


Page 10 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
In addition, use of Dapagliflozin is also associated with a risk of weight loss (up to 10 lbs 
over 12 weeks).
ARE THERE ANY BENEFITS FROM TAKING PART IN THIS STUDY? 
There are no direct benefits in participating, however you will receive a copy of your 
results and information pertinent to your body composition (i.e. height and weight), and 
metabolic and cardiovascular risk factors. For example, in blood we will measure 
concentrations of glucose.  You will be provided with a copy of your DEXA scan; you 
may wish to have this interpreted by a medically qualified professional. Finally, this study 
has the potential to identify an additional benefit for people who use Dapagliflozin to treat 
their type 2 diabetes.  
DO I HAVE TO TAKE PART IN THE STUDY?
Your participation in this research is voluntary. If you decide to participate in the study, 
you may withdraw your consent and stop participating at any time without penalty or 
loss of benefits to which you are otherwise entitled.
WHAT WILL IT COST ME TO PARTICIPATE? 
Other than transport to and from the lab, your participation should incur no costs. You 
will not be charged for your supervised exercise training.
WHO WILL SEE THE INFORMATION THAT I GIVE? 
We will keep private all research records that identify you, to the extent allowed by law.
For this study, we will assign a code to your data (e.g. 1234ABCD) so that the only place 
your name will appear in our records is on the consent and in our data spreadsheet that
links you to your code. Only the research team will have access to the link between you, 
your code, and your data. The only exceptions to this are if we are asked to share the 
records of the study for audit purposes with the Food and Drug Administration, Health 
and Human Services, AstraZeneca, and/or the CSU Institutional Review Board ethics 
committee, if necessary. In addition, for funded studies, the CSU financial management 
team may also request an audit of research expenditures. For financial audits, only the 
fact that you participated would be shared, not any research data. When we write about 
the study to share it with other researchers, we will write about the combined information 
we have gathered. You will not be identified in these written materials. We may publish 
the results of this study; however, we will keep your name and other identifying 
information private.
Your identity/record of receiving compensation (NOT your data) may be made available 
to CSU officials for financial audits.
CAN MY TAKING PART IN THE STUDY END EARLY? 


Page 11 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
If you do not complete 40 exercise sessions (approximately 90%), or two exercise 
sessions within a 7-day period, you will be removed from the study. If you fail to ingest 
90% of your Dapagliflozin or placebo (75/84 pills) you will be removed from the study.
Your participation in the study will end if you become pregnant.
WILL I RECEIVE ANY COMPENSATION FOR TAKING PART IN THIS STUDY? 
If you complete all 51 of the visits, and all of the procedures as described, you may
receive $300 in total. This payment will be paid in installments and prorated as follows: 
you will not receive compensation for visit 1 (the screening visit). You will receive $80 on
completion of visits 2, 3 and 4.  You will not receive compensation for visits 5-48; nor will 
you be charged for this supervised exercise training.  You will receive $60 for completion 
of visit 49. You will receive $60 for completion of visit 50. You will receive $60 for 
completion of visit 51. If you attend 100% of your scheduled visits, and arrive no later 
than 10 minutes after the scheduled appointment time for all appointments, you will 
receive a bonus of $40.
Should your participation in the study end early, you will still receive feedback pertaining 
to your health and fitness. 
WHAT HAPPENS IF I AM INJURED BECAUSE OF THE RESEARCH?
We will arrange to get you medical care if you have an injury that is caused by this 
research.
CSU will pay for medical expenses for the treatment of a personal injury that is a direct 
result of the administration of the study drug (CSU will be reimbursed by AstraZeneca). 
CSU will not provide compensation for lost wages or for any other damages, expenses 
or losses, or for medical expenses that have been covered by medical insurance.
Should you sustain an injury that is not the direct result of the study drug, you or your 
insurance company may have to pay for the required care. The Colorado Governmental 
Immunity Act determines and may limit Colorado State University, University of 
Colorado Denver and University of Colorado Hospital’s legal responsibility if an injury 
happens because of this study. Claims against the University must be filed with 
Colorado State University within 180 days of the injury.
WHAT IF I HAVE QUESTIONS?  
Before you decide whether to accept this invitation to take part in the study, please ask 
any questions that might come to mind now.  Later, if you have questions about the 
study, you can contact the investigator, Dr. Bell via email:
physiology@cahs.colostate.edu. If you have any questions about your rights as a 
volunteer in this research, contact the CSU IRB at: RICRO_IRB@mail.colostate.edu;
970-491-1553. We will give you a copy of this consent form to take with you.


Page 12 of 12 Participant’s initials _______ Date _______
Version 01July2016
CSU#: 14-5529H
APPROVED: 11/16/2017* EXPIRES: 11/15/2018
WHAT ELSE DO I NEED TO KNOW? 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov as 
required by U.S. Law. This website will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this website at 
any time.  
Your signature acknowledges that you have read the information stated and willingly 
sign this consent form.  Your signature also acknowledges that you have received, on 
the date signed, a copy of this document containing 12
pages.
___________________________________________
_____________
Signature of person agreeing to take part in the study
Date
_____________________________________________
_____________
Printed name of person agreeing to take part in the study
Time of Day
_________________________________________
_____________
Name of person providing information to participant
Date
_________________________________________  
Signature of Research Staff