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Mechanisms of Diabetes Control After Weight Loss Surgery
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), January 2009
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00571220
  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

MedlinePlus related topics: Diabetes Obesity Weight Control Weight Loss Surgery
Drug Information available for: Glucagon-like peptide 1
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Mechanisms of Diabetes Control After Weight Loss Surgery

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

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

blood samples


Estimated Enrollment: 20
Study Start Date: September 2005
Estimated Study Completion Date: July 2009
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571220

Contacts
Contact: Blandine Laferrere, MD 212 5234643 bbl14@columbia.edu

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

Publications of Results:
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

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

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Weight Loss
Body Weight Changes
Diabetes Mellitus
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on January 13, 2009