Type 2 Diabetes Mellitus
Conditions
Keywords
Gastric Bypass, bariatric surgery, carbohydrate metabolism
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.
Interventions
DRUGExendin 9, 39
Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
DRUGPlacebo
A saline infusion will be given to match the study drug infusion.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Adrian Vella
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Disposition Index from Study 1 (Exendin 9,39) to Study 2 (saline) | Day 1, Day 2 (approximately 2 weeks after day 1) | The total disposition index equals the product of insulin secretion and insulin sensitivity. |
Countries
United States
Outcome results
None listed