Clinical trial NCT02985853: Longitudinal Assessment of Bariatric Surgery Sub-Study
Official title: Longitudinal Assessment of Bariatric Surgery Sub-Study: A Prospective, Longitudinal Cohort Study of the Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery (LABS-3 DIABETES)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Diabetes Mellitus
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-12-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be selected from the LABS-2 cohort at participating LABS clinical centers.

Brief summary: The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.

Detailed description: The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced by the changes in incretin function, together with improvement in insulin resistance induced by weight loss, normalize glucose homeostasis in type 2 DM.

Funds are not available to pay for the surgery for patients, only to address research questions.

Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
* Enrollment in LABS-1 or LABS-2.
* Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
* Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
* Adequate IV access.

Exclusion Criteria:

* Informed consent not obtained.
* Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
* Creatinine greater than 1.7.
* Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
* Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).

Primary outcomes:
measure: Weight
timeFrame: Up to 72 months
measure: Capillary Blood Glucose
timeFrame: Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: