The Effect of Roux-en-Y Gastric Bypass on Insulin Sensitivity in Type 2 Diabetes

October 24, 2013 updated by: Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital
Gastric bypass surgery induces remission of diabetes within days after surgery, before significant weight loss. The aim of the study is to examine whether improved insulin sensitivity of muscle and liver contributes to the immediate diabetes resolution.

Study Overview

Status

Completed

Conditions

Detailed Description

Obesity has become a severe epidemic globally. With the rapid increase in obesity comes a pronounced rise in obesity-related disorders, especially type 2 diabetes. Weight loss achieved through lifestyle changes improves diabetes, but is very difficult to maintain over time. In contrast, Roux-en-Y gastric bypass (RYGB) surgery can induce long-term weight loss and remission of diabetes. Surprisingly, the resolution of type 2 diabetes occurs within days after surgery and before significant weight loss. The resolution of diabetes must therefore be explained by a response to the surgical alterations of the stomach and intestines: restriction in gastric volume and bypass of the stomach, duodenum and proximal jejunum.

Severe insulin resistance in muscle and liver is the common defect in obesity and type 2 diabetes and may be improved or even reversed shortly after the operation. The aim of this study is to examine the acute changes in insulin sensitivity of muscle and liver by using hyperinsulinaemic euglycaemic clamp combined with glucose tracer to assess hepatic glucose production. Insulin signaling pathways will be studied in biopsies from muscle and subcutaneous fat as to explain the molecular basis of the changes in insulin sensitivity after RYGB.

Insulin secretion will be evaluated in response to oral glucose as well as iv glucose-glucagon.

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

  • Denmark
    • Hvidovre
      • Copenhagen, Hvidovre, Denmark, DK-2650
        • Hvidovre University Hospital

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are recruited from the outpatient clinic of endocrinology and gastrosurgical clinic at Hvidovre University Hospital

Description

Inclusion Criteria:

  • patients eligible for gastric bypass surgery
  • Verified type 2 diabetes or normal glucose tolerance by oral glucose tolerance test (OGTT)

Exclusion Criteria:

  • Treatment for Hyperthyroidism

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
RYGB patients with type 2 diabetes
Morbid obese patients with type 2 diabetes undergoing gastric bypass surgery
RYGB patients without type 2 diabetes
Morbid obese patients with normal glucose tolerance undergoing gastric bypass surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in insulin sensitivity after RYGB
Time Frame: 1 week, 3 months, 1 year
1 week, 3 months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in insulin secretion in response to oral glucose after RYGB
Time Frame: 3 months, 1 year
3 months, 1 year

Other Outcome Measures

Outcome Measure
Time Frame
Change in insulin secretion after iv glucose-glucagon after RYGB
Time Frame: 1 week, 3months, 1 year
1 week, 3months, 1 year

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Collaborators

University of Copenhagen

Investigators

  • Principal Investigator: Anna Kirstine Bojsen-Møller, MD, Hvidovre University Hospital

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

September 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISBypass

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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