Mechanisms of Diabetes Relapse After Bariatric Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by New York Obesity and Nutrition Research Center
Sponsor:
Information provided by (Responsible Party):
Blandine Laferrere, MD, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01516320
First received: January 19, 2012
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to understand the mechanisms of type 2 diabetes remission and relapse after Gastric Bypass Surgery (GBP). The investigators will be studying the effect of glucose and hormones on the production of insulin.

The investigators expect to find that individuals who have a relapse of diabetes after GBP have a weaker insulin secretion response to various stimuli. Subjects with Diabetes relapse will also be less sensitive to insulin, and will have more body fat.


Condition
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Mechanisms of Diabetes Relapse After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by New York Obesity and Nutrition Research Center:

Primary Outcome Measures:
  • Difference in insulin secretion between groups. [ Time Frame: 2-8 Weeks ] [ Designated as safety issue: No ]
    The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.


Secondary Outcome Measures:
  • Difference in Incretin hormone response between groups. [ Time Frame: 2-8 ] [ Designated as safety issue: No ]
    The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.

  • Difference in Body composition between groups [ Time Frame: 2-8 Weeks ] [ Designated as safety issue: No ]
    The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.


Biospecimen Retention:   Samples With DNA

Serum, Pellet, Urine, Stool, Saliva


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes Relapse after GBP
Participants who are at least 1 year post GBP surgery, AND had documented Type 2 Diabetes before surgery AND currently have Type 2 Diabetes as per American Diabetes Association diagnostic criteria.
Diabetes Remission after GBP
Participants who are at least 1 year post GBP surgery, AND who had documented Type 2 Diabetes prior to surgery AND currently have normal glucose tolerance as per American Diabetes Association criteria.
Weight Matched Non-Operated Controls
Participants who have never had any kind of bariatric surgery, are overweight to moderately obese, and have no personal or family history of Type 1, Type 2, or Gestational Diabetes.

Detailed Description:

The purpose of this study is to understand the mechanisms of type 2 diabetes remission and relapse after Gastric Bypass Surgery (GBP).

In this cross sectional study, three groups will be studied:

  1. Patients who have undergone GBP at least 1 year ago, had documented type 2 diabetes prior to GBP and currently have persistent or relapsed diabetes.
  2. Patients who have undergone GBP at least 1 year ago, had documented type 2 diabetes prior to GBP and are currently in full diabetes remission.
  3. Overweight or moderately obese patients without any diabetes, who have not undergone bariatric surgery.

At the New York Obesity Research Center of St. Luke's Roosevelt Hospital Center in New York City, The investigators will study approximately 12-15 patients from each of these groups for a total of approximately 40 patients.

Patients will have four appointments each, which will take place over the course of approximately 2 to 8 weeks. Over the four visits the investigators will assess insulin secretion in response to oral and various intravenous nutrient or hormonal stimuli. Body composition will be assessed to look at fat mass and distribution.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Sample primarily drawn from the community surrounding St. Luke's-Roosevelt Hospital Center. Post-GBP groups will primarily be drawn from patients of the St. Luke's-Roosevelt Hospital Center Bariatric Surgery Division.

Criteria

Inclusion Criteria: Post GBP Subjects

  • Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
  • At least 1 year post GBP surgery
  • History of Type 2 Diabetes before surgery

Inclusion Criteria: Non-Operated Overweight to Moderately Obese Controls

  • Must be able to attend 4 study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
  • No personal or family history of Type 1, Type 2 or Gestational Diabetes
  • BMI between ~24-42

Exclusion Criteria:

  • Active cancer, unstable angina, recent stroke.
  • Current therapy with medications that may affect glucose metabolism such as glucocorticoids, adrenergic agents, etc.
  • Evidence of a medical condition that might alter results or compromise the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure
  • Pregnancy: A pregnancy test will be done prior to enrollment and to each procedure in all premenopausal women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516320

Contacts
Contact: Antonia Colarusso RD, Clinical Co-Ordinator (212) 523-3581 tcolarus@chpnet.org

Locations
United States, New York
New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center Not yet recruiting
New York, New York, United States, 10025
Principal Investigator: Blandine Laferrere, MD         
Sponsors and Collaborators
Blandine Laferrere, MD
Investigators
Principal Investigator: Blandine Laferrere, MD New York Obesity Nutrition Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Blandine Laferrere, MD, Associate Professor of Medicine, St. Luke's-Roosevelt Hospital Center, Columbia University, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01516320     History of Changes
Other Study ID Numbers: LAF34
Study First Received: January 19, 2012
Last Updated: January 23, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by New York Obesity and Nutrition Research Center:
Type 2 Diabetes
Gastric Bypass

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014