By InvitationPhase 2/3

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

United States30 participantsStarted 2024-10-30

Plain-language 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). 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.

Who can participate

Age range25 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Weight loss

Timeframe: baseline to 24 weeks

Trial details

NCT IDNCT06162715

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

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