Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

September 9, 2015 updated by: St. Luke's-Roosevelt Hospital Center
Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.

Study Type

Observational

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
        • St. Luke's Roosevelt Hospital-New York Obesity Nutrition Research 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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

severly obese patients with type 2 diabetes undergoing gastric bypass or gastric banding

Description

Inclusion Criteria:

  • obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery

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

Cohorts and Interventions

Group / Cohort
gastric bypass
Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
gastric banding
surgical group of obese patients with type 2 diabetes undergoing gastric banding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Incretin Effect
Time Frame: Before surgery, 1, 12, and 24 months post
Effect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP)
Before surgery, 1, 12, and 24 months post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body Composition
Time Frame: Before surgery, 12, and 24 months post
Body composition measurements to determine body volume, size, and fat
Before surgery, 12, and 24 months post

Collaborators and Investigators

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

Sponsor

St. Luke's-Roosevelt Hospital Center

Collaborators

National Institutes of Health (NIH)

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

September 1, 2008

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 20, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 9, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-108

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.

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