Effect of Gastric Bypass Surgery on Pancreatic Islets and Incretin Function

Completed

• Conditions: Obesity

• Registration Number: NCT01559779
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2012-07
• Study Completion: 2012-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-09
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in beta cell function	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
Insulinotropic effect of incretin hormones	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

Name	Time	Method
Change in alpha cell function	Before and 1 week and 3 months after surgery	Change in glucagon secretion in response to glucose and non-glucose stimuli

Trial Locations

Locations (1)

Dpt. of Endocrinology (215) at Hvidovre Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark