Clinical trial NCT03469492
Conditions: Hyperglycaemia (Diabetic)
Sponsor: Yale University
Start date: 2018-01-18; Completion date: 2020-03-20
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.

Detailed description:
Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.

Arms: arm 1: Subjects with type 2 diabetes on insulin. arm 2: Subjects with type 1 diabetes on insulin.
Interventions: intervention 1: Insulin intervention 2: exercise intervention 3: Dietary counseling
Intervention descriptions: intervention 1: Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level. intervention 2: Exercise in accordance to the guidelines established by the American Diabetes Association. intervention 3: Dietary counseling in accordance to the guidelines established by the American Diabetes Association.

Protocol documents:
Prot_SAP_000.pdf: 



















































ICF_001.pdf: 
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COMPOUND AUTHORIZATION AND CONSENT FOR PARTICIPATION IN A RESEARCH 
PROJECT
200 FR. 4 ( 2014-1) 
YALE UNIVERSITY SCHOOL OF MEDICINE – YALE-NEW HAVEN HOSPITAL
Diabetic Subjects
Invitation to Participate
You are invited to take part in a research study designed to look at the effects of high blood glucose 
levels on the production of fructose in the brain. You have been asked to take part because you are an individual 
with type 1 or type 2 diabetes between the ages 18 and 65 years old.
In order to decide whether or not you wish to be a part of this research study you should know enough 
about its risks and benefits to make an informed decision.  This consent form gives you detailed information 
about the study, which a member of the research team will discuss with you.  This discussion should go over all 
aspects of this research: its purpose, the procedures that will be performed, any risks of the procedures, and 
possible benefits. Once you understand the study, you will be asked if you wish to participate; if so, you will be 
asked to sign this form.
Description of Project
Growing evidence suggests that fructose is linked to the development of obesity and diabetes. Studies 
investigating the central nervous system (CNS) effects of fructose have shown that fructose and glucose, two 
different types of sugars, have distinct metabolic effects in the brain.
In this study, we seek to better understand a biological pathway called the polyol pathway by which 
fructose can be produced from glucose in the brain. We plan to use a non-invasive brain imaging technique 
called magnetic resonance spectroscopy (MRS). A greater understanding of the role of the polyol pathway in 
the brain may have important implications for understanding the effects of fructose in the human brain.
TITLE:
Investigating the role of the polyol pathway in the central 
nervous system production of fructose: an Intervention 
Study
PROTOCOL NO:
2000026149
INVESTIGATOR:
Janice Hwang, MD 
Yale University School of Medicine
300 Cedar street, TAC S-119
PO Box 208020
New Haven, CT 06520
STUDY-RELATED NO: 
(203) 737-4777 
Funding Source:
National Institutes of Health
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Description of Procedures
Screening visit: If you agree to participate in the study, you will have a screening visit at the YNHH Research 
Unit (HRU). A study doctor will take a medical history and perform a physical exam. Blood tests will be 
collected to ensure that you do not have any major medical problems, which would exclude you from the study. 
You will also undergo an oral glucose tolerance test. Female subjects will also have a urine pregnancy test prior 
to study participation.
Optional blood collection at the screening visit:
During the screening visit, you have the option to have an additional 50 cc of blood collected for a sub-study 
related to assessing the effects of diabetes and obesity on the body’s immune system. 
I agree to participate in the optional blood collection as described above: (initial your choice)
_____YES
______No
Intensification of Diabetes regimens: If you qualify and agree to participate in the study, you may undergo 
intensification of your diabetes regimen. This process will be managed by Dr. Hwang, a fully trained attending 
endocrinologist, and will follow the general strategies outlined in the Position Statement of the American 
Diabetes Association and the European Association for the Study of Diabetes. Additionally, you will be asked 
to perform self-monitoring of blood glucose (SMBG) at least 4 times a day (before breakfast, lunch, dinner, and 
bedtime). The daily SMBG records will be sent to Dr. Hwang weekly for review to guide adjustment of diabetes 
regimens. You will be in contact with Dr. Hwang via phone, email and consultation visits. 
Nutrition Consultations: You will be in communication with a nutritionist regularly over the course of the 12-
week study. The nutritionist will provide you with dietary counseling. 
MRI/MRS (magnetic resonance imaging and spectroscopy) scanning: If you qualify medically for the 
study, you will return for brain MRI/MRS scanning as described below. MRI and MRS are non-invasive scans 
that will be used to take pictures that tell us about structures and chemicals in your brain.
MRS at week 0, and 12: At weeks 0, and 12 you will undergo a fasting MRI/MRS scanning of your brain at 
the Yale Magnetic Resonance Research Center (MRRC). This scan will last ~45 minutes. You will have blood 
work drawn at that time for glucose and hormone measurements.
Phlebotomy: The maximum amount of blood that will be drawn is approximately 549 cc or 18.5 oz over the 3 
months of the study if you complete the entire study (including the optional hyperglycemic cl
amp portions 
described below). If you agree to participate in the optional hyper glycemic portions, blood draws include: 5cc 
at the screening visit, 272 cc at week 0 visit, and 272cc at week 12. If you choose not to do the optional 
hyperglycemic clamp portion of the study, the total blood draw will be approximately 202cc or 7 oz over the 
course of the study. Blood draws include: 5cc at screen, 98.5cc at week 0 visit, and 98.5 cc at week 12. For 
reference, a typical donation at the Red Cross is 16 oz. We would advise you not to donate blood for at least 8 
weeks after the completion of the study.
Optional Overnight Admissions and Hyper Glycemic Clamps at Weeks 0 and 12: You have the option to 
participate in an overnight stay and hyperglycemic clamp at the beginning (week 0) and end (week 12) of the 
study. If you choose to participate, you will arrive in the evening prior to your MRS scan day to the YNHH 
HRU. You will be admitted overnight. There, your diabetic medications will be held and an IV will be placed 
for an insulin infusion that will be adjusted to keep your blood sugar levels in the 100-110 mg/dL range, while 
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avoiding hypoglycemia (glucose <70 mg/dL).  The insulin infusion protocol is based on the standard YNHH 
inpatient hospital insulin drip protocol.
The next morning, you will be taken to the MRRC for the MRS scan while your blood sugar levels are adjusted.
One intravenous catheter will be placed in a vein in one arm to sample blood at different time points. A second 
IV will be placed in the other arm for infusion of dextrose (which is a glucose solution) at a variable rate to 
maintain your blood glucose levels at about 200 mg/dL for 2 hours.  
 A nurse experienced with working in a MRS environment will be with you at all times. A study physician will 
be outside the scanner during the entire study. 
I agree to participate in the overnight stay and hyperglycemic clamp at weeks 0 and 12 of the study: (initial your 
choice)
_____YES
______No
Continuous Glucose Monitoring System (CGMS): You will wear a continuous glucose monitor for two 14-
day intervals. These 14day blocks correspond to the weeks before the week 0 and week 12 MRS scans. After 
first placing the CGM prior to the week 0 scan, the system is removed after 14 days and then reinserted for 14 
days before the week 12 MRS scan. We will monitor your interstitial (under the skin) glucose levels 
throughout the day with the use of a CGMS. The CGMS consists of two parts: monitor and sensor/transmitter. 
The small glucose sensor/transmitter, size of quarter coin, is discreet and easy to use. It connects wirelessly to 
the monitor (size of a mobile phone), that you should carry with you in your pocket, belt or handbag. One of the 
study physicians will insert the CGMS wire-like tip under your skin and attaches it to the skin with an adhesive 
patch. You will need to do at least two finger-stick measurements during the day as well with a glucose meter.  
You will need to wear the glucose sensor for 5 days while completing the food diary. The CGMS and glucose 
meter will be provided to you while you are participating in the study.
Questionnaires and Surveys
Throughout the study (before each MRS scan), you will be asked to fill out some questionnaires with questions 
about your feelings of hunger, satiety and fullness as well as some cognitive testing.
Optional Specimens for Future Storage
You are invited to allow some of your samples (called specimens) and related information to be stored (banked) 
for future research related to hormones involved in obesity and diabetes, and the study of other chemical 
pathways and metabolic diseases.  This may help researchers in the future learn more about how to prevent, find 
and treat obesity and diabetes.
When your specimens and information are stored, we are careful to try to protect your identity from discovery 
by others.  Your samples and information will receive a unique code.  Other researchers will only receive coded 
samples and information and will not be able to link the code to you.  Some of the researchers who will be 
provided the de-identified samples may not be on the current research protocol and may be at other research 
centers. Strict security safeguards are in place to reduce the chance of misuse or unplanned release of 
information. Your samples and related information may be stored indefinitely for future research.
Using your specimens for research will probably not help you.  We do hope the research results will help people 
in the future.
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There is a risk that your information could be misused. The chance of this happening is very small.  We have 
protections in place to lower this risk by de-identifying the samples with your name and personal identifiers.  
Your specimens and information will only be used for research and will not be sold.  There is a possibility that 
this research may lead to development of products that will be commercialized.  If this happens, there is no plan 
to share any financial gain with you.
Research results will not be returned to you or your doctor.  If research results are published, your name and 
other personal information will not be given.
The choice to take part is up to you.  You may choose not to let us store and use your samples, and your care 
will not be affected by this decision.  If you decide that your samples can be kept, you may change your mind at 
any time.  Contact the study staff at 203-785-6222 to let them know you do not want your samples used any 
longer.  You may choose to have your samples either destroyed or made anonymous (the code linking them to 
you will be destroyed).  You must follow up this request with a written request, mailed to 300 Cedar Street, 
TAC 147S, New Haven CT 06519.
I agree to allow my samples and information to be stored and used for future research as described above: 
(initial your choice)
_____YES
______No
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 
This Web site will not include information that can identify you. At most, the Web site will include a summary 
of the results. You can search this Web site at any time.
You will be told of any significant new findings that are developed during the course of your participation in 
this study that may affect your willingness to continue to participate.
Risks and Inconveniences
Hyperglycemia clamp:
The infusion of glucose to achieve hyperglycemia (~200 mg/dl) for 2 hours is not associated with any 
specific symptoms or significant adverse effects. This modestly high glucose level can be seen in poorly 
controlled diabetic patients following a meal. 
The overnight infusion of insulin to normalize plasma glucose levels is normally not associated with any 
specific symptoms. There is a small risk that plasma glucose may fall to lower levels resulting in symptoms of 
hypoglycemia.
MRI/MRS:
Magnetic resonance (MR) is a technique that uses magnetism and radio waves, not x-rays, to take 
pictures and measure chemicals of various parts of the body.  The United States Food and Drug Administration 
(FDA) has set guidelines for magnet strength and exposure to radio waves, and we carefully observe those 
guidelines.  
You will be watched closely throughout the MR study.  Some people may feel uncomfortable or 
anxious.  If this happens to you, you may ask to stop the study at any time and we will take you out of the MR 
scanner.  On rare occasions, some people might feel dizzy, get an upset stomach, have a metallic taste or feel 
tingling sensations or muscle twitches.  These sensations usually go away quickly but please tell the research 
staff if you has any of these symptoms.
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There are some risks with an MR study for certain people.  If you have a pacemaker or some metal 
objects inside your body, you may not be in this study because the strong magnets in the MR scanner might 
harm you.  Another risk is the possibility of metal objects being pulled into the magnet and hitting you.  To 
reduce this risk we require that all people involved with the study remove all metal from their clothing and all 
metal objects from their pockets.  We also ask all people involved with the study to walk through a detector 
designed to detect metal objects.  It is important to know that no metal can be brought into the magnet room at 
any time.  Also, once you are in the magnet, the door to the room will be closed so that no one from outside 
accidentally goes near the magnet.
We want you to read and answer very carefully the questions on the MR Safety Questionnaire related to 
your personal safety.  Take a moment now to be sure that you have read the MR Safety Questionnaire and be 
sure to tell us any information about you that you think might be important.  
This MR study is for research purposes only and is not in any way a clinical examination.  The scans 
performed in this study are not designed to find abnormalities. 
The primary investigator, the lab, the MR technologist, and the Magnetic Resonance Research Center 
are not qualified to interpret the MR scans and are not responsible for providing a diagnostic evaluation of the 
images.  If a worrisome finding is seen on your scan, a radiologist will be asked to review the relevant images.  
Based on his or her recommendation (if any), the primary investigator or consulting physician will contact you, 
inform you of the finding regarding you, and recommend that you seek medical advice as a precautionary 
measure.  The decision for additional examination or treatment would lie solely with you and your physician.  
The investigators, the consulting physician, the Magnetic Resonance Research Center, and Yale University are 
not responsible for any examination or treatment that you receive based on these findings.  The images collected 
in this study are not a clinical MR exam and for that reason, they will not be made available for diagnostic 
purposes.
CGMS:
The CGMS poses no major risks to the subjects. Some individuals may experience black and blueness of the 
skin at the insertion site of the CGMS sensor, which resolves by itself in a few days.
Phlebotomy:
Phlebotomy can result in anemia, although the amount of blood taken for these studies should not result in 
clinically-significant anemia. We will check your hemoglobin level to make sure that you are not anemic before 
participating in this study. The total amount of blood taken for participation in this study will be approximately 
18.5 ounces over a 12 week period.
Breach of Confidentiality: It is possible that an unauthorized individual may gain access to your private 
information. We will make every effort to keep your data safe and private. For more information about how 
your data is protected, please review the “Confidentiality and Privacy” paragraph on the next page.
Benefits: You may not directly benefit from your participation in this study. Subjects will be provided with 
FreeStyle Libre sensors throughout the study (9 sensors are provided during the 12 weeks that the study last), 
and FreeStyle Libre continuous glucose monitor reader. All participants will receive exercise and dietary 
counseling in accordance with ADA guidelines and increased frequency of medical attention to lower their 
blood glucose to target ranges.  However, the results of this study may lead to better understanding of the 
pathways in the brain that are involved in obesity and diabetes.
Economic Considerations: You will be compensated up to $600 for participation in the study.  The breakdown 
is as follows: 
$  25 for the screening visit  
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$50 for wearing the CGMS at week -1
$150 for overnight admission/Hyperglycemic clamp/MRS scans at week 0
$50 for wearing the CGMS at week 11
$ 325 for overnight admission/Hyperglycemic clamp/MRS scans at week 12
You will receive payments via a Bank of America pre-paid debit card.  Please note that your name, address, 
and telephone number will be shared with Bank of America for ePayments. After your first payment 
milestone (your first study visit) you will receive a card in the mail which you will need to activate over the 
phone, any subsequent milestones payments will automatically add additional funds to your card. 
You may also be reimbursed for incidental expenses for parking.
‘According to the rules of the Internal Revenue Service (IRS), payments that are made to you as a result 
of your participation in a study may be considered taxable income.’
Treatment Alternatives/Alternatives: The alternative is to decline participation in this study.
Confidentiality and Privacy
Any identifiable information that is obtained in connection with this study will remain confidential and will be 
disclosed only with your permission or as permitted by U.S. or State law.  Examples of information that we are 
legally required to disclose include abuse of a child or elderly person, or certain reportable diseases. As a 
participant in a clinical research study involving an outpatient visit to the Yale-New Haven Hospital (YNHH) 
Research Unit (HRU).  It is important for you to know that if you do not already have a medical record at 
YNHH; one will be made for your visit. Some information related to the care given to you during this visit will 
become part of your YNHH medical record. For example, any laboratory test results that are sent to the YNHH 
lab for testing will appear in your medical record and any printed copies of your record.  In addition, you need 
to know that when any person is admitted to the YNHH, the individual's previous medical records of other visits 
or admissions to YNHH become available to physicians and hospital staff in order to ensure that the best 
possible care can be provided to the individual during the hospital stay. Similarly, the researchers and staff of 
the HRU will have access to whatever information is already in your YNHH medical records such as past 
surgeries or medical conditions, emergency room visits, or possibly clinic visits when you are admitted to the 
HRU. If such access to your past medical history by researchers and staff responsible for the study is 
unacceptable to you, then you should not participate in the research study.
When the results of the research are published or discussed in conferences, no information will be included that 
would reveal your identity unless your specific consent for this activity is obtained.  
We understand that information about you obtained in connection with your health is personal, and we are 
committed to protecting the privacy of that information.  If you decide to be in this study, the researcher will get 
information that identifies you and your personal health information.  This may include information that might 
directly identify you, such as your name and your personal health information. This information will be de-
identified at the earliest reasonable time after we receive it, meaning we will replace your identifying 
information with a code that does not directly identify you. The principal investigator will keep a link that 
identifies you to your coded information, and this link will be kept secure and available only to the PI or 
selected members of the research team. Any information that can identify you will remain confidential.  
All identifiable information that is obtained in connection with this study is stored in password protected secure 
computer data files, and will remain confidential and will be disclosed only with your permission or as required 
by U.S. or State law. All of the information obtained in this study is kept in locked files and will be kept 
confidential. When the study is completed subject information is stored at least for 7 years in locked cabinets 
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within a locked storage unit that only the investigators of the study have access to. When the results of the 
research are published or discussed in conferences, no information will be included that would reveal your 
identity unless your specific consent for this activity is obtained. The research team will only give this coded 
information to others to carry out this research study. The link to your personal information will be kept for 7 
years, after which time the link will be destroyed and the data will become anonymous. 
The information about your health that will be collected in this study includes: 
Medical history
Physical exams
Laboratory results
Imaging results
Research study records and questionnaires
Information about you and your health which might identify you may be used by or given to: 

The U.S. Department of Health and Human Services (DHHS) agencies

The U.S. Food and Drug Administration (FDA) This is done so that the FDA can review information about 
drugs involved in this research. The information may also be used to meet the reporting requirements of 
drug regulatory agencies.

Representatives from Yale University, the Yale Human Research Protection Program and the Yale Human 
Investigation Committee (the committee that reviews, approves, and monitors research on human 
subjects), who are responsible for ensuring research compliance.  These individuals are required to keep 
all information confidential. 

Those individuals at Yale who are responsible for the financial oversight of research including billings 
and payments

The Principal Investigator, Dr. Janice Hwang

Health care providers who provide services to you in connection with this study.

Laboratories and other individuals and organizations that analyze your health information in connection 
with this study, according to the study plan.

Co-Investigators and other investigators 

Study Coordinator and Members of the Research Team 

Bank of America
By signing this form, you authorize the use and/or disclosure of the information described above for this 
research study.  The purpose for the uses and disclosures you are authorizing is to ensure that the information 
relating to this research is available to all parties who may need it for research purposes.
All health care providers subject to HIPAA (Health Insurance Portability and Accountability Act) are 
required to protect the privacy of your information.  The research staff at the Yale School of Medicine and 
Yale-New Haven Hospital are required to comply with HIPAA and to ensure the confidentiality of your 
information.  Some of the individuals or agencies listed above may not be subject to HIPAA and therefore 
may not be required to provide the same type of confidentiality protection. They could use or disclose your 
information in ways not mentioned in this form.  However, to better protect your health information, 
agreements are in place with these individuals and/or companies that require that they keep your information 
confidential. 
You have the right to review and copy your health information in your medical record in accordance with 
institutional medical records policies. 
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This authorization to use and disclose your health information collected during your participation in this study 
will never expire.
 If you decide to take part in this research study, you will be required to give us information about your 
substance use/ /HIV status. We have obtained a Certificate of Confidentiality (CoC) issued by the NIH. Once 
granted, the researchers can use this Certificate to legally refuse to disclose information that may identify you in 
any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there 
is a court subpoena. The researchers will use the Certificate to resist any demands for information that would 
identify you, except as explained below.  
The protection offered by the CoC does not stop us from voluntarily reporting information about suspected or 
known sexual, physical, or other abuse of a child or older person, or a participant’s threats of violence to self or 
others. If any member of the research team is given such information, he or she will make a report to the 
appropriate authorities. When the CoC is obtained, we will inform all active study participants.
Because this research is sponsored by the Department of Health and Human Services through NIH, staff from 
that and other DHHS agencies may review records that identify you only for audit or program evaluation. They 
cannot report anything that would harm you or other research subjects.  
Even when a CoC is in place, you and your family members must still continue to actively protect your own 
privacy. If you voluntarily give your written consent for anyone to receive information about your participation 
in the research, then we may not use the CoC to withhold this information.”
In Case of Injury
If you are injured while on study, seek treatment and contact the study doctor as soon as you are able.  Yale 
School of Medicine and Yale-New Haven Hospital do not provide funds for the treatment of research-related 
injury.  If you are injured as a result of your participation in this study, treatment will be provided.  You or your 
insurance carrier will be expected to pay the costs of this treatment.  No additional financial compensation for 
injury or lost wages is available. You do not give up any of your legal rights by signing this form.
Voluntary Participation and Withdrawal
Participating in this study is voluntary. You are free to choose not to take part in this study.   Refusing to 
participate will involve no penalty or loss of benefits to which you are otherwise entitled (such as your health 
care outside the study, the payment for your health care, and your health care benefits).  However, you will not 
be able to enroll in this research study and will not receive study procedures as a study participant if you do not 
allow use of your information as part of this study.
Withdrawing From the Study
If you do become a subject, you are free to stop and withdraw from this study at any time during its course. To 
withdraw from the study, you can call a member of the research team at any time and tell them that you no 
longer want to take part.  This will cancel any future appointments. The researchers may withdraw you from 
participating in the research if any of the study physicians think that it is not safe for you to participate in the 
study. Withdrawing from the study will involve no penalty or loss of benefits to which you are otherwise 
entitled.  It will not harm your relationship with your own doctors or with Yale-New Haven Hospital.
Withdrawing Your Authorization to Use and Disclose Your Health Information
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You may withdraw or take away your permission to use and disclose your health information at any time. You 
may withdraw your permission by telling the study staff or by writing to Dr. Janice Hwang at Yale University, 
300 Cedar Street, TAC 147S, New Haven, CT 06519. If you withdraw your permission, you will not be able to 
stay in this study.
When you withdraw your permission, no new health information identifying you will be gathered after that 
date.  Information that has already been gathered may still be used and given to others until the end of the 
research study, as necessary to insure the integrity of the study and/or study oversight.  
Questions
We have used some technical terms in this form.  Please feel free to ask about anything you don't 
understand and to consider this research and the consent form carefully – as long as you feel is necessary – 
before you make a decision.
Contact for future studies
We ask for your permission to contact you for participation in future studies that our group may conduct. We 
may use your telephone number, your email address or your physical address to contact you. 
I agree to be contacted regarding future studies I may qualify for: (Initial for choice)
________ YES                     ________NO
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Authorization and Permission
I have read (or someone has read to me) this form and have decided to participate in the project described 
above.  Its general purposes, the particulars of my involvement and possible hazards and inconveniences have 
been explained to my satisfaction.  My signature also indicates that I have received a copy of this consent form.
By signing this form, I give permission to the researchers to use [and give out] information about me for the 
purposes described in this form.  By refusing to give permission, I understand that I will not be able to be in this 
research. 
Name of Subject:_____________________________
                        
Signature:___________________________________
Date:______________________________________
___________________________________________
___________________
Signature of Principal Investigator
Date
                                      or
___________________________________________
___________________
Signature of Person Obtaining Consent
Date
If after you have signed this form you have any questions about your privacy rights, please contact the Yale 
Privacy Officer at 203/432-5919.
If you have further questions about this project or if you have a research-related problem, you may contact the 
Principal Investigator, Dr. Janice Hwang, 203-785-6222. If you would like to talk with someone other than the 
researchers to discuss problems, concerns, and questions you may have concerning this research, or to discuss 
your rights as a research subject, you may contact the Yale Human Investigation Committee at (203) 785-4688. 
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