Effects of bariatric surgeries on glucose metabolism
The Effects of Bariatric Surgeries on Glucose Metabolism
This study tests how gastric bypass and sleeve gastrectomy surgeries affect blood sugar control after meals in people with diabetes to see which surgery might work better.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (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 | NCT02823665 on ClinicalTrials.gov |
What this trial studies
This study investigates how gastric bypass surgery and sleeve gastrectomy influence glucose metabolism through neural and hormonal factors after meals. It aims to assess the weight-independent effects of these surgeries on islet cell response and to compare the two surgical procedures. The findings could lead to new treatment strategies for diabetes and enhance the glycemic outcomes for patients experiencing partial diabetes remission or relapse following surgery.
Who should consider this trial
Good fit: Ideal candidates include hypoglycemic patients who have undergone gastric bypass surgery, asymptomatic individuals post-bariatric surgery, and healthy non-surgical individuals without a history of diabetes.
Not a fit: Patients with active serious medical conditions, type 2 diabetes, or a personal history of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that improve diabetes management and glycemic control in patients undergoing bariatric surgery.
How similar studies have performed: Other studies have shown promising results in understanding the metabolic effects of bariatric surgeries, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hypoglycemic RYGB patients with documented blood glucose level \<50 mg/dl * Asymptomatic individuals with bariatric surgery * Healthy non-surgical patients with no personal history of diabetes * Subjects must physically be able to come to our clinical research center Cedars-Sinai Medical Center Exclusion Criteria: * Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin \<11g/dL); prisoners or institutionalized individuals; type 2 diabetes mellitis; development of any serious medical or psychiatric illness during recruitment or studies; * RYGB patients will be disqualified if they have gastric outlet obstruction or severe diarrhea. * Healthy non-surgical patients with personal history of diabetes For administration of atropine, the following exclusions also apply: * History of glaucoma * Uncontrolled hypertension (any subjects with BP\>140/90 and history of dyslipidemia * Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study) * Myasthenia gravis * Brain pathology * Enlarged prostate in men
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 — The University of Texas Health Science Center at San Antonio
- 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.