Effect of Gastric Bypass Surgery on Pancreatic Islet and Incretin Function - Follow-up Study

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161666
• Other study ID #: AB-CD-10-2Y
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: April 3, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

To examine pancreatic islet function and incretin function during intravenous and oral stimulation >2 years after gastric bypass surgery in patients with normal glucose tolerance. We hypothesize that islet cell and incretin function is enhanced in response to oral, but not intravenous, stimulation - i.e. incretin released from the gut in response to oral stimulation play a key role for the enhanced islet function after gastric bypass surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participation in previous study (NCT01559779)

Exclusion Criteria:

• Pregnancy/lactation

• Major chronic disease develop since previous examination with possible impact on outcomes

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in islet cell function from baseline (preoperatively)	Change in insulin and glucagon secretion during oral and intravenous stimulation after gastric bypass	>24 months	No
Secondary	Change in glucose tolerance during oral glucose tolerance test	Fasting, peak and nadir glucose during oral glucose tolerance test	>24 months	No
Secondary	Arterio-venous glucose difference during oral glucose tolerance test after gastric bypass	Differences in arterial and venous plasma glucose during oral glucose stimulation	>24 months	No