Mechanisms of Diabetes Relapse After Bariatric Surgery (LAF26)

January 30, 2017 updated by: Blandine Laferrere
The objective of this study is to investigate the different mechanisms by which Gastric Bypass (GBP), laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly obese patients with Type 2 Diabetes Mellitus after GBP, LAGB or VSG. The 2 surgical groups will be compared at 10% equivalent weight loss and at after surgery in terms of gut hormones levels, insulin secretion and glucose control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The mechanisms of type 2 diabetes (T2DM) remission after gastric bypass surgery (GBP) are unclear. The levels of the gut hormones incretins and their effect on insulin secretion, which is impaired in T2DM, markedly increase after GBP. The anatomical changes of GBP, rather than weight loss, seem to be responsible for the changes of incretins. The objective of this proposal is to investigate the different mechanisms by which GBP, laparoscopic adjustable gastric banding (LAGB) and vertical sleeve gastrectomy (VSG) affect glucose control. We wish to understand the role of weight loss versus changes in gut peptides in the short and long term in morbidly patients with T2DM after GBP, LAGB or VSG.

AIM 1: Will study the short term changes of incretins levels and effect in obese individuals with T2DM after GBP, LAGB or VSG, before and 1 month after GBP or before and after equivalent weight loss after LAGB or VSG.

AIM 2: Will study the long-term (12 and 24 months after surgery) changes in the incretin effect on insulin secretion, in patients with T2DM after GBP, LAGB or VSG.

AIM 3: Will study the changes of insulin secretion to IV glucose (AIRg) and insulin sensitivity (Si), measured by the minimal model, in patients with T2DM after GBP, VSG or LAGB, before and at 24 months after the surgery, at weight stability under condition of controlled diet.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Post GBP, LAGB or VSG Subjects

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

Inclusion Criteria:

  • 35 < BMI < 50
  • Non-Smoker
  • Total Body Weight < 300 LBS
  • 30<Age<60
  • HbA1c < 9%
  • Resting Blood Pressure < 160/100 mmHg
  • Beta Blockers discontinued 2 weeks prior
  • Fasting Triglyceride Concentration < 600 mg/dl (patient can be on dyslipidemia medications)
  • Without recent (within last 6 months) CHD history (prior history of angioplasty or coronary artery bypass surgery with normal stress test ok)

Exclusion Criteria:

  1. Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
  2. Patients should not have significant secondary complications from diabetes that would preclude undergoing gastric by-pass surgery. This would include significant psychiatric, renal or neurological, or known active coronary artery disease.
  3. Any abnormality during the maximum exercise stress test that indicates it would be unsafe to undergo bariatric surgery.
  4. Currently pregnant or nursing.
  5. Known cardiovascular disease
  6. Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
  7. HbA1c >9% and diabetes diagnosed more than 6 years prior to enrollment, or patients taking insulin or TZD (Avandia, Actos, Exenatide, DPP-IV inhibitors etc.) at the time of enrollment.
  8. Patients diagnosed with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome. These clinical conditions would interfere with the collection and interpretation of the H2 breath test.
  9. Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastric Bypass (GBP) Subjects
Subjects enrolled in the study who are receiving Roux-en-Y Gastric Bypass surgical technique for treatment of their obesity.
Procedure: Roux-en-Y Gastric Bypass
A surgical technique in which the stomach is stapled into a smaller pouch and then attached directly to the small intestine, bypassing the rest of the original stomach. The goal of the surgery is weight loss.
Active Comparator: Laparoscopic adjustable gastric banding (LAGB) Subjects
Subjects enrolled in the study who are receiving laparoscopic adjustable gastric banding surgical technique for treatment of their obesity.
Procedure: Laparoscopic adjustable gastric banding
A surgical technique in which an inflatable silicone device placed around the top portion of the stomach, creating a smaller gastric pouch. The goal of the surgery is weight loss.
Active Comparator: Vertical Sleeve Gastrectomy (VSG) Subjects
Subjects enrolled in the study who are receiving vertical sleeve gastrectomy surgical technique for treatment of their obesity.
Procedure: Vertical Sleeve Gastrectomy
A surgical technique in which a large portion of the stomach is removed, leaving only a smaller gastric pouch. The goal of the surgery is weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in insulin secretion between groups.
Time Frame: 0 - 48 months after surgery
The investigators will assess insulin secretion in response to oral and intravenous nutrient and hormonal stimuli in the three groups.
0 - 48 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Incretin hormone response between groups.
Time Frame: 0 - 48 months after surgery
The investigators will assess the endogenous incretin response to oral glucose stimulus after GBP.
0 - 48 months after surgery
Difference in Body composition between groups
Time Frame: 0 - 48 months after surgery
The investigators will assess body composition (fat mass and fat distribution) in the 3 groups.
0 - 48 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blandine Laferrere

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2009

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAO1101
  • R01DK067561 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on Roux-en-Y Gastric Bypass

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe