The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass

Type 2 Diabetes Mellitus Clinical Trial

Official title:

The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843881
• Other study ID #: 11-007667
• Secondary ID: R01DK082396UL1RR
• Status: Completed
• Phase: Phase 0
• First received: April 26, 2013
• Last updated: December 3, 2013
• Start date: March 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study is being undertaken to understand how the Roux-en-Y Gastric Bypass procedure can affect insulin secretion after meals. The hypothesis of this study is the Disposition Index is decreased in subjects who had previously undergone Roux-en-Y Gastric Bypass by glucagon-like peptide-1 (GLP-1) receptor blockade.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria Roux-en-Y Gastric Bypass (RYGB)Subjects:

• Subjects who have undergone RYGB

Inclusion Criteria Healthy Subjects:

• Must match RYGB subjects in age, weight, and gender

• Subjects will be without active systemic illness

Exclusion Criteria all Subjects:

• Subjects <20 years old and >70 years old

• For Female Subjects: positive pregnancy text at the time of enrollment or study

• Subjects with functional or organic bowel symptoms.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Exendin 9, 39
Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
• Placebo
A saline infusion will be given to match the study drug infusion.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Adrian Vella	National Center for Research Resources (NCRR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)	The total disposition index equals the product of insulin secretion and insulin sensitivity.	Day 1, Day 2 (approximately 2 weeks after day 1)	No