Preoperative Tirzepatide for Bariatric Surgery

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy, or gastric bypass surgery

• BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities

• have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing

• enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Marlene Starr, PhD
marlene.starr@uky.edu
859-323-0471
Backup
Varun Jain, MD
vja233@uky.edu
Time Frame
Start Date: 2025-03-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Standard of Care plus Drug
Participant receives drug for 3 months prior to surgery
Active_comparator: Standard of Care Alone
Related Therapeutic Areas
Sponsors
Leads: Marlene Starr

This content was sourced from clinicaltrials.gov