Understanding how gastric bypass surgery affects glucose metabolism
The Role of Glucagon Like Peptide-1 in Glucose Metabolism and Weight Loss Following Gastric Bypass Surgery
This study is trying to see how gastric bypass surgery helps people manage their blood sugar better by looking at certain hormones and their effects on insulin in patients who have had the surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 2 sites (San Antonio, Texas and 1 other locations) |
| Trial ID | NCT01803451 on ClinicalTrials.gov |
What this trial studies
This project aims to explore the mechanisms by which gastric bypass surgery enhances glucose metabolism. It focuses on the role of incretin hormones in insulin secretion among patients who have undergone Roux-en-Y gastric bypass. The study involves three specific aims: assessing incretin hormones' impact on insulin secretion, comparing glucose tolerance in patients with and without hypoglycemia post-surgery, and quantifying the contribution of GLP-1 to the incretin effect after surgery. The methodology includes using an intravenous-oral hyperglycemic clamp to gather data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 who have undergone gastric bypass surgery and experience recurrent hypoglycemia.
Not a fit: Patients with significant anemia, diabetes (unless pre-operative for bariatric surgery), or gastrointestinal obstruction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of glucose metabolism in patients post-bariatric surgery.
How similar studies have performed: Other studies have shown promising results in understanding incretin hormones and glucose metabolism, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age 18-65 * healthy control without diabetes or active organ disease * Individuals with bariatric surgery * recurrent hypoglycemia post gastric bypass Exclusion Criteria: * pregnancy * significant anemia * diabetes currently unless pre-op for bariatric surgery procedure * GI obstruction
Where this trial is running
San Antonio, Texas and 1 other locations
- Texas Diabetes Institute - University Health System — San Antonio, Texas, United States (Recruiting)
- South Texas Veterans Health Care System — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Marzieh Salehi, MD,MS — Marzieh Salehi
- Study coordinator: Marzieh Salehi, MD MS
- Email: salehi@uthscsa.edu
- Phone: 210-567-6691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.