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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00571220 |
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.
Condition | Intervention |
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Surgical Condition Before and After Gastric Bypass Surgery Diet Condition: Before and After a Weight Loss Equivalent to What Patients Lose 1 Month After GBP 9approximately 10kg) |
Procedure: gastric bypass surgery Other: Diet induced weight loss |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Mechanisms of Diabetes Control After Weight Loss Surgery |
blood samples
Estimated Enrollment: | 20 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | July 2009 |
Groups/Cohorts | Assigned Interventions |
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1
Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
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Procedure: gastric bypass surgery
weight loss bariatric surgery
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2
Diet group of obese patient with type 2 diabetes, matched with the surgical group for diabetes duration, diabetes control (HbA1C), BMI, age.
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Other: Diet induced weight loss
low calorie diet with meal replacements. weekly outpatient visits with nutritionist.
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Ages Eligible for Study: | 21 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Morbidly obese patients with type 2 diabetes of less than 5 years duration
Inclusion Criteria:
Exclusion Criteria:
Contact: Blandine Laferrere, MD | 212 5234643 | bbl14@columbia.edu |
United States, New York | |
St Luke's Roosevelt Hospital Center | Recruiting |
New York, New York, United States, 10025 | |
Contact: Blandine Laferrere, MD bbl14@columbia.edu | |
Principal Investigator: Blandine Laferrere, MD |
Principal Investigator: | Blandine Laferrere, MD | St. Luke's-Roosevelt Hospital Center |
Responsible Party: | St Luke's-Roosevelt Hospital Center ( Blandine Laferrere, M.D./Principal Investigator ) |
Study ID Numbers: | DK67561 |
Study First Received: | December 7, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00571220 |
Health Authority: | United States: Federal Government |
gastric bypass diabetes obesity |
diet-induced weight loss incretin levels (GLP-1,GIP) incretin effect |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Diabetes Mellitus Glucagon-Like Peptide 1 |