Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function (AB-CD-10)

June 9, 2014 updated by: Carsten Dirksen, Hvidovre University Hospital

The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones

The study aims at describing the acute and subacute changes after Roux-en-Y (RYGB) gastric bypass in insulin secretion from the beta cell and glucagon secretion from the alpha cell as well as the stimulatory effect of the incretins on the pancreatic islets. RYGB is a bariatric procedure that changes the gastrointestinal anatomy and has been demonstrated to cause remission of type 2 diabetes shortly after the operation, before any significant weight loss. The altered transit of nutrient through the gastrointestinal tract after the operation is thought to play a key role in this remission and studies have shown significant changes in the secretion of gut hormones, namely the incretin hormone glucagon-like peptide-1 (GLP-1). However it is unknown whether the secretory function of the pancreatic islets as well as the stimulatory effect of the incretin hormones is changes postoperatively.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11

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
    • Copenhagen
      • Hvidovre, Copenhagen, Denmark, 2650
        • Dpt. of Endocrinology (215) at Hvidovre 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital

Description

Inclusion Criteria:

  • Normal glucose tolerance
  • Age > 18 years
  • BMI > 40 or > 35 if combined with hypertension or obstructive sleep apnoea
  • Caucasian
  • Normal hemoglobinaemia
  • Signed informed consent

Exclusion Criteria:

  • Major psychiatric disorder
  • Alcohol or drug abuse
  • Major hearth or pulmonary disease
  • Previous major abdominal disease (e.g. peritonitis, large hernia)
  • Pregnancy/lactation
  • Treatment with GLP-1 analogs

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
Normal glucose tolerance
Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in beta cell function
Time Frame: Before and 1 week and 3 months after surgery
Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus
Before and 1 week and 3 months after surgery
Insulinotropic effect of incretin hormones
Time Frame: Before and 1 week and 3 months after surgery
Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline
Before and 1 week and 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in alpha cell function
Time Frame: Before and 1 week and 3 months after surgery
Change in glucagon secretion in response to glucose and non-glucose stimuli
Before and 1 week and 3 months after surgery

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: Carsten Dirksen, 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

November 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-CD-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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