RecruitingPhase 4NCT06721507

2024 Tirzepatide-Bariatric Surgery

Preoperative Tirzepatide for Bariatric Surgery


Sponsor

Marlene Starr

Enrollment

50 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery. Participants will: Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months. Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug. Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 4 clinical trial tests whether taking tirzepatide — a weekly injectable medication that promotes weight loss — for three months before bariatric surgery (sleeve gastrectomy or gastric bypass) can reduce inflammation in the body at the time of surgery and improve outcomes afterward, including greater weight loss, better metabolic health, and fewer surgical complications. Adults enrolled in a bariatric surgery program with a BMI of 40 or above plus at least one obesity-related condition, who are scheduled for laparoscopic or robotic weight loss surgery and have confirmed nicotine abstinence, are eligible. Participants take tirzepatide or no medication (depending on group assignment) for 3 months, visit the endocrine clinic monthly, and continue with their planned surgery and follow-ups. People with a personal or family history of medullary thyroid cancer, pancreatitis, type 1 diabetes, or active gallbladder disease are excluded. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGtirzepatide

Participants will be educated on dietary and lifestyle changes. Participants will self inject 2.5 mg tirzepatide subcutaneously once weekly and maintain a drug administration diary. Dose escalation will proceed per package directions if instructed by study team at follow up visits.

BEHAVIORALStandard of Care

Participants will be educated on dietary and lifestyle changes


Locations(1)

University of Kentucky

Lexington, Kentucky, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06721507


Related Trials