The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Exendin 9, 39
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Gastric Bypass, bariatric surgery, carbohydrate metabolism
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exendin 9, 39
Placebo
Arm Description
Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.
A saline infusion will be administered in either first intervention period or second intervention period.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01843881
First Posted
April 26, 2013
Last Updated
December 3, 2013
Sponsor
Adrian Vella
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT01843881
Brief Title
The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
Official Title
The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adrian Vella
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Gastric Bypass, bariatric surgery, carbohydrate metabolism
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exendin 9, 39
Arm Type
Experimental
Arm Description
Exendin 9, 39 will be infused at 300pmol/kg/min in either first intervention period or second intervention period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A saline infusion will be administered in either first intervention period or second intervention period.
Intervention Type
Drug
Intervention Name(s)
Exendin 9, 39
Intervention Description
Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A saline infusion will be given to match the study drug infusion.
Primary Outcome Measure Information:
Title
Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline)
Description
The total disposition index equals the product of insulin secretion and insulin sensitivity.
Time Frame
Day 1, Day 2 (approximately 2 weeks after day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Vella, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Contribution of Incretin Hormones to Post-prandial Glucose Metabolism After Roux-en-Y Gastric Bypass
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