Actively Recruiting
2024 Tirzepatide-Bariatric Surgery
Led by Marlene Starr · Updated on 2026-05-14
50
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
2024 Tirzepatide-Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults enrolled in the UK HealthCare Weight Loss Surgery Clinic metabolic and bariatric surgery program scheduled for laparoscopic or robotic sleeve gastrectomy or gastric bypass surgery
- Body mass index (BMI) of 40 kg/m2 or higher with one or more obesity-related comorbidities
- Demonstrated abstinence from any form of nicotine use confirmed by serum nicotine and metabolite testing
- Enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
You will not qualify if you...
- Any contraindication to tirzepatide use as per package insert
- Personal or family history of medullary thyroid carcinoma
- Diagnosis of Multiple Endocrine Neoplasm syndrome type 2
- Hypersensitivity to tirzepatide
- History of pancreatitis
- Diagnosis of Type 1 Diabetes
- Active, untreated, or symptomatic cholelithiasis or jaundice
- Consistent use of GLP-1 or GLP-1/GIP receptor agonists in the past 90 days
- Diagnosed autoimmune disease
- Current use or use within past 30 days of immunosuppressive agents
- Moderate or severe substance use disorder according to DSM-5 criteria
- Uncontrolled significant psychiatric disorder as assessed by a specialized bariatric psychologist
- Female who is pregnant, breastfeeding, or intends to become pregnant within one year following surgery
- Prisoner
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40506
Actively Recruiting
Research Team
M
Marlene Starr, PhD
CONTACT
V
Varun Jain, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here