Text Size

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

This study is currently recruiting participants.
Verified March 2012 by Hvidovre University Hospital
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Carsten Dirksen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01559779
First received: March 19, 2012
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Type 2 Diabetes
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Gastric Bypass Surgery on the Beta- and Alpha Cells Secretory Function and the Insulinotropic Effect of the Incretin Hormones

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Change in beta cell function [ Time Frame: Before and 1 week and 3 months after surgery ] [ Designated as safety issue: No ]
    Change in first and second phase insulin response, disposition index, and acute insulin secretion in response to a non-glucose stimulus

  • Insulinotropic effect of incretin hormones [ Time Frame: Before and 1 week and 3 months after surgery ] [ Designated as safety issue: No ]
    Change in first and second phase insulin response during GLP-1 and GIP infusion compared to saline


Secondary Outcome Measures:
  • Change in alpha cell function [ Time Frame: Before and 1 week and 3 months after surgery ] [ Designated as safety issue: No ]
    Change in glucagon secretion in response to glucose and non-glucose stimuli


Biospecimen Retention:   Samples Without DNA

Plasma and serum specimens are retained


Estimated Enrollment: 24
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal glucose tolerance
Morbidly obese subjects with normal glucose tolerance undergoing gastric bypass surgery
Type 2 diabetes
Morbidly obese subjects with type 2 diabetes undergoing gastric bypass surgery

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Clear diabetes status
  • Age > 18 years
  • BMI > 40 or > 35 if combined with type 2 diabetes, 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
  • Insulin-dependent diabetes
  • Treatment with GLP-1 analogs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559779

Contacts
Contact: Carsten Dirksen, MD +4536326374 carsten.dirksen@hvh.regionh.dk

Locations
Denmark
Dpt. of Endocrinology (215) at Hvidovre Hospital Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Carsten Dirksen, MD     +4536326374     carsten.dirksen@hvh.regionh.dk    
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Investigators
Principal Investigator: Carsten Dirksen, MD Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Carsten Dirksen, MD PhD student, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01559779     History of Changes
Other Study ID Numbers: AB-CD-10
Study First Received: March 19, 2012
Last Updated: March 20, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Type 2 diabetes
Obesity
Roux-en-Y gastric bypass
Incretin hormones
Beta cell function

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013