Mechanisms of Diabetes Control After Weight Loss Surgery

Study Overview
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Brief Summary
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Obesity and type 2 diabetes (T2DM) are increasing in the US. One third of patients seeking bariatric surgery have T2DM. Although all surgeries result in significant weight loss and often 'cure' the T2DM, the rapid onset and the magnitude of the benefits of gastric bypass (GBP) on T2DM has thus far baffled clinical scientists. Limited data suggest that the improvement in T2DM after GBP occurs very rapidly, and may not be wholly accounted for by weight loss. Secretion of incretins (gut peptides secreted in response to meals which enhance insulin secretion) is impaired in T2DM and improves after GBP, possibly due to the specific anatomical changes after this surgery. While some determinants of impaired insulin secretion, such as glucotoxicity, improve equally after diet or surgical weight loss, the improvement in the incretin effect after GBP might be specific to this surgery. The aim of this study is to determine whether the magnitude of the incretin effect on insulin secretion is greater after GBP than after an equivalent diet-induced weight loss. We will compare, in obese patients with diabetes, randomized to very low calorie diet or to GBP, the effect of an equivalent weight loss on the incretin effect (difference in insulin secretion after comparable oral and intravenous (IV) glucose loads). As more obese diabetic patients undergo GBP, understanding the mechanisms that produce improvement in their diabetes is increasingly important.

Official Title
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Mechanisms of Diabetes Control After Weight Loss Surgery

Conditions
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Gastric Bypass Surgery, Obesity

Intervention / Treatment
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* Procedure: gastric bypass surgery
* Other: Diet induced weight loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet. Exclusion Criteria: any condition that would be contra-indicated for bariatric surgery (ex:unstable angina) diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors HbA1C > 8%

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric bypass surgery<br>Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery | Procedure: gastric bypass surgery<br>* weight loss bariatric surgery<br>|
| Diet induced weight loss<br>Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age. | Other: Diet induced weight loss<br>* low calorie diet with meal replacements. weekly outpatient visits with nutritionist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in incretin | Change in incretin (gastric inhibitory peptide [GIP] and glucagon-like peptide-1 [GLP-1]) | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, gastric bypass, diabetes, diet-induced weight loss, incretin levels (GLP-1,GIP), incretin effect