GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Nov 30, 2023

Keywords

ClinConnect Summary

Obesity affects nearly half of the U.S. population, impacting health outcomes including diabetes, cardiovascular risk, longevity, and quality of life. While bariatric surgery such as gastric bypass stands as the most effective intervention, 65% of individuals experience persistent obesity when undergoing surgical weight loss alone. Given the wide-ranging impact of obesity on health outcomes, a critical need exists to explore the efficacy of adjuvant weight loss therapies after gastric bypass surgery. Tirzepatide (TRZ), a type of glucagon-like peptide-1 receptor agonist, shows remarkable eff...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject must be able to understand and provide informed consent.
• • 2. BMI \> 30 12 months after bariatric surgery.
• • 3. Age \> 30 and \< 65
• • 4. Patients undergoing primary Roux-en-Y Gastric Bypass
• Exclusion Criteria:
• • 1. Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
• • 2. Diagnosis of type I Diabetes
• • 3. Revisional bariatric surgery (prior adjustable gastric band, sleeve gastric, vertical banded gastroplasty).
• • 4. Use of medications for type 2 di
• • 5. Hemoglobin A1c \> 8.5 in last 3 months.
• • 6. Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery.
• • 7. Personal history of pancreatitis as determined by history.
• • 8. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2
• • 9. Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period.
• • 10. Use of systemic glucocorticoids in the past 28 days
• • 11. Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history.
• • 12. History of solid organ transplant.
• • 13. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years.
• • 14. Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism.
• • 15. Current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.
• • 16. Screening creatinine elevation with EGFR \< 60 at time of randomization.
• • 17. Tobacco use in last 12 months
• • 18. Pregnancy
• • 19. Prisoners
• • 20. Unable or unwilling to follow-up
• • 21. Unable to understand English/Spanish

Trial Officials