Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function

Obesity Clinical Trial

— AB-CD-10  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01559779
• Other study ID #: AB-CD-10
• Status: Completed
• Phase: N/A
• First received: March 19, 2012
• Last updated: June 9, 2014
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Denmark	Dpt. of Endocrinology (215) at Hvidovre Hospital	Hvidovre	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in beta cell function	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	No
Primary	Insulinotropic effect of incretin hormones	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	No
Secondary	Change in alpha cell function	Change in glucagon secretion in response to glucose and non-glucose stimuli	Before and 1 week and 3 months after surgery	No