Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
- Conditions
- Post-bariatric Surgery
- Interventions
- Drug: exendin -(9-39)Drug: exendin-(9-39)
- Registration Number
- NCT01803451
- Brief Summary
The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.
The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.
1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.
- Detailed Description
The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.
The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.
1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- age 18-65
- healthy control without diabetes or active organ disease
- Individuals with bariatric surgery
- recurrent hypoglycemia post gastric bypass
- pregnancy
- significant anemia
- diabetes currently unless pre-op for bariatric surgery procedure
- GI obstruction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Labeled meal tolerance test exendin -(9-39) The effect of GLP-1 receptor blockade on glucose tolerance and glucose kinetics are evaluated in the group patients with bariatric surgery vs. nonsurgical using exendin-9-39 infusion during one of the the 2-day dual tracer studies of meal tolerance test hyperglycemic clamp-Meal tolerance test exendin-(9-39) these studies are to evaluate the effect of exendin-9 on insulin secretion before and after meal ingestion in patients after bariatric surgeries compared to non-surgical controls
- Primary Outcome Measures
Name Time Method The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated up to 1 year (10 sessions)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Texas Diabetes Institute - University Health System
🇺🇸San Antonio, Texas, United States
South Texas Veterans Health Care System
🇺🇸San Antonio, Texas, United States