Mechanisms of Diabetes Control After Weight Loss Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-09-30

Study Completion Date

2010-12-31

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.

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Detailed Description

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Conditions

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Gastric Bypass Surgery Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric bypass surgery

Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery

gastric bypass surgery

Intervention Type PROCEDURE

weight loss bariatric surgery

Diet induced weight loss

Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age.

Diet induced weight loss

Intervention Type OTHER

low calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Interventions

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gastric bypass surgery

weight loss bariatric surgery

Intervention Type PROCEDURE

Diet induced weight loss

low calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Intervention Type OTHER

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%

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No