Status:
ENROLLING_BY_INVITATION
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Severe Obesity
Obesity
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI \> 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). ...
Detailed Description
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 st...
Eligibility Criteria
Inclusion
- Subject must be able to understand and provide informed consent.
- BMI \> 30 12 months after bariatric surgery.
- Age \> 30 and \< 65
- Patients undergoing primary Roux-en-Y Gastric Bypass
Exclusion
- Inability or unwillingness of a subject to give written informed consent or comply with the study protocol.
- Diagnosis of type I Diabetes
- Revisional bariatric surgery (prior adjustable gastric band, sleeve gastric, vertical banded gastroplasty).
- Use of medications for type 2 di
- Hemoglobin A1c \> 8.5 in last 3 months.
- Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery.
- Personal history of pancreatitis as determined by history.
- Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2
- Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period.
- Use of systemic glucocorticoids in the past 28 days
- Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history.
- History of solid organ transplant.
- History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years.
- Current uncontrolled hypertension (systolic \>150, diastolic \>90) or untreated hyperthyroidism.
- 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.
- Screening creatinine elevation with EGFR \< 60 at time of randomization.
- Tobacco use in last 12 months
- Pregnancy
- Prisoners
- Unable or unwilling to follow-up
- Unable to understand English/Spanish
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06162715
Start Date
October 30 2024
End Date
December 1 2027
Last Update
December 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37209