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

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ClinicalTrials.gov Identifier: NCT01559779
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : June 10, 2014
University of Copenhagen
Information provided by (Responsible Party):
Carsten Dirksen, Hvidovre University Hospital

Brief Summary:
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 or disease

Study Type : Observational
Actual Enrollment : 11 participants
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
Study Start Date : November 2010
Primary Completion Date : July 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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

  2. 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

Secondary Outcome Measures :
  1. 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

Biospecimen Retention:   Samples Without DNA
Plasma and serum specimens are retained

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects are recruited from the population undergoing gastric bypass surgery at Hvidovre Hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559779

Dpt. of Endocrinology (215) at Hvidovre Hospital
Hvidovre, Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Principal Investigator: Carsten Dirksen, MD Hvidovre University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carsten Dirksen, MD PhD student, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01559779     History of Changes
Other Study ID Numbers: AB-CD-10
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

Keywords provided by Carsten Dirksen, Hvidovre University Hospital:
Roux-en-Y gastric bypass
Incretin hormones
Beta cell function

Additional relevant MeSH terms:
Gastric Inhibitory Polypeptide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents