Mechanisms of Diabetes Control After Weight Loss Surgery

March 7, 2018 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

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 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

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • morbidly obese with type 2 diabetes candidates and being evaluated at our institution for bariatric surgery (group1); morbidly obese patients with type 2 diabetes who want to lose weight by diet.

Exclusion Criteria:

  • any condition that would be contra-indicated for bariatric surgery (ex:unstable angina)
  • diabetes treated by insulin, thiazolidinediones (TZD), exenatide, DPP-IV inhibitors
  • HbA1C > 8%

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastric bypass surgery
Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery
Procedure: gastric bypass surgery
weight loss bariatric surgery
Diet induced weight loss
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in incretin
Time Frame: One month
Change in incretin (gastric inhibitory peptide [GIP] and glucagon-like peptide-1 [GLP-1])
One month

Collaborators and Investigators

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

Sponsor

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

Investigators

  • Principal Investigator: Blandine Laferrere, MD, St. Luke's-Roosevelt Hospital Center

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.

General Publications

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)

September 1, 2005

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK67561 (completed)
  • R01DK067561 (U.S. NIH Grant/Contract)

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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