Type 2 Diabetes Mellitus
Conditions
Keywords
Gastric Bypass, bariatric surgery, glucose metabolism
Brief summary
The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
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
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of \> 110 mg/dL * Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).
Exclusion criteria
* Subjects taking thiazolidinediones * Subjects with active systemic illness * Subjects with active microvascular or macrovascular complications of their diabetes * For female subject: positive pregnancy test at the time of enrollment in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB) | baseline, 4 weeks post-operative intervention | The total disposition index equals the product of insulin secretion and insulin sensitivity. |
Countries
United States
Outcome results
None listed