Longitudinal Assessment of Bariatric Surgery Sub-Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Obesity, Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight measurements will take place at every visit, up to 72 months after bariatric surgery. | Up to 72 months | 
| Capillary Blood Glucose | Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure. | Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure. |