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Mechanisms of Diabetes Control After Weight Loss Surgery

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ClinicalTrials.gov Identifier: NCT00571220
Recruitment Status : Unknown
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
First Posted : December 11, 2007
Last Update Posted : February 10, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
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 Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mechanisms of Diabetes Control After Weight Loss Surgery
Study Start Date : September 2005
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
Procedure: gastric bypass surgery
weight loss bariatric surgery
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
low calorie diet with meal replacements. weekly outpatient visits with nutritionist.

Outcome Measures

Biospecimen Retention:   Samples Without DNA
blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Morbidly obese patients with type 2 diabetes of less than 5 years duration

Inclusion Criteria:

  • morbidly obese with type 2 diabetes candidates and being evaluated at our instituion for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lsoe weight by diet.

Exclusion Criteria:

  • any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)
  • diabetes treated by insulin, TZD, exenatide, DPP-IV inhibitors
  • HbA1C > 8%
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00571220

United States, New York
St Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Blandine Laferrere, MD St. Luke's-Roosevelt Hospital Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Blandine Laferrere, M.D./Principal Investigator, St Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00571220     History of Changes
Other Study ID Numbers: DK67561 (completed)
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: February 10, 2011
Last Verified: February 2011

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
gastric bypass
diet-induced weight loss
incretin levels (GLP-1,GIP)
incretin effect

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Pathologic Processes
Body Weight Changes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs