Mechanisms of Diabetes Control After Weight Loss Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00571220
First received: December 7, 2007
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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
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: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mechanisms of Diabetes Control After Weight Loss Surgery

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention:   Samples Without DNA

blood samples


Estimated Enrollment: 20
Study Start Date: September 2005
Estimated Study Completion Date: December 2010
Groups/Cohorts Assigned Interventions
1
Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
Procedure: gastric bypass surgery
weight loss bariatric surgery
2
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.

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Morbidly obese patients with type 2 diabetes of less than 5 years duration

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00571220

Locations
United States, New York
St Luke's Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
Investigators
Principal Investigator: Blandine Laferrere, MD St. Luke's-Roosevelt Hospital Center
  More Information

Publications:
Additional 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)
Study First Received: December 7, 2007
Last Updated: February 9, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Body Weight
Disease
Weight Loss
Body Weight Changes
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014