Gastric Bypass Surgery for Type 2 Diabetes
Trial Summary
What is the purpose of this trial?
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are not understood, recent studies suggest that increased secretion of GI hormones, primarily glucagon-like peptide 1 (GLP-1), as well as alteration in neural activity may contribute to enhanced insulin secretion in general, and to a greater extent in patients with hypoglycemia. The proposed research is designed to address the role of RYGB on insulin secretion by evaluating the contribution of stimulatory factors (neural and GI hormone) on islet cell function and the islet cell responsiveness to the physiologic stimulatory factors, in RYGB patients with and without hypoglycemia and non-operated controls.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking any medication that might interact with atropine and cannot be stopped, you will be excluded from the study.
What data supports the effectiveness of the drug for treating type 2 diabetes?
Research shows that GLP-1 and GIP, components of the drug, help regulate blood sugar and insulin levels, making them effective for treating type 2 diabetes. Additionally, a study on a similar dual receptor agonist in mice demonstrated improved glucose tolerance and reduced obesity-related issues, suggesting potential benefits for humans.12345
How does gastric bypass surgery differ from other treatments for type 2 diabetes?
Gastric bypass surgery is unique because it physically alters the digestive system to help with weight loss and improve blood sugar control, unlike medications that primarily focus on insulin regulation. This surgery can lead to significant and sustained weight loss, which can improve or even resolve type 2 diabetes in some patients.14678
Research Team
Marzieh Salehi, MD, MS
Principal Investigator
Marzieh Salehi
Eligibility Criteria
This trial is for individuals who've had gastric bypass surgery and either have low blood sugar episodes or are symptom-free. It's also open to healthy people without diabetes. Participants must be able to visit Cedars-Sinai Medical Center but can't join if they have certain conditions like an enlarged prostate, glaucoma, serious organ diseases, uncontrolled hypertension or cholesterol, significant anemia, or are pregnant.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive experimental treatments to evaluate the role of GLP-1 signaling, neural activation, and beta-cell sensitivity to gut hormones
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atropine (Other)
- Exendin-(9-39) (Other)
- GLP-1 and GIP (Hormone Therapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Dr. Andrew Masica
The University of Texas Health Science Center at San Antonio
Chief Medical Officer
MD from Indiana University School of Medicine
Dr. Taylor Eighmy
The University of Texas Health Science Center at San Antonio
Acting President
PhD in Civil Engineering from the University of New Hampshire