Clinical trial

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

Active, not recruiting · Phase 2, Phase 3 · 1 countries · Registry ID NCT06162715

Active, not recruitingPhase 2, Phase 3Interventional

What this study is about

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). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who continue with the current standard of care for patients who have previously undergone Gastric Bypass Surgery.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionSevere Obesity, Obesity, BMI Greater Than 30

Full registry criteria

Inclusion Criteria: 1. Subject must be able to understand and provide informed consent. 2. BMI \> 30 12 months after bariatric surgery. 3. Age \> 25 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

Treatments and study arms

Tirzepatide

Drug

Tirzepatide will be initiated 12 or 18 months (12 months + 24 weeks) after patients undergo Roux-en-Y Gastric Bypass. Patients will be started on the lowest dose of 2.5 mg and the dose increased every 6 weeks following an adaptive maximum dose titration protocol. Patients will then complete a final 4 weeks of the study drug.

Standard of Care post-gastric bypass

Other

Patients randomized to the control arm will receive the standard of care for weight maintenance after gastric bypass including dietary guidance provided by the Vanderbilt Surgical Weight Loss handbook. This includes recommendations for 64 oz of fluids per day, ≥60 grams of protein/day, and daily bariatric multivitamins. Patients will continue to have access to dedicated bariatric dietitians, advanced practice providers, and surgeons on an ad hoc basis per patients' request.

Primary outcomes

Weight lossbaseline to 24 weeks

Change in weight over time.

Gastrointestinal symptomsbaseline to 24 weeks

We will measure the average PAGI SYM score from 0 - 24 weeks in both arms.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Vanderbilt University Medical Center🇺🇸 Nashville, Tennessee, United States