Using tirzepatide before bariatric surgery to improve outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates whether administering tirzepatide prior to bariatric surgery can enhance postoperative outcomes for patients. The study aims to evaluate the effects of tirzepatide on inflammatory markers and its correlation with weight loss, metabolic improvements, and surgical complications. Participants will be assigned to either receive tirzepatide or standard care for three months before their scheduled laparoscopic or robotic sleeve gastrectomy. The results could inform future therapeutic guidelines for obesity treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* any contraindication to the use of tirzepatide (per package insert)
* Personal or family history of medullary thyroid carcinoma
* Patients with Multiple Endocrine Neoplasm syndrome type 2
* Hypersensitivity to tirzepatide
* History of pancreatitis
* Type 1 Diabetes
* patients with active, untreated or symptomatic cholelithiasis or jaundice
* consistent use of a GLP-1 or GLP-1/GIP receptor agonist, over the past 90 days
* diagnosed autoimmune disease
* current use of immunosuppressive agents or use within the past 30 days
* moderate or severe substance use disorder according to DSM-5 criteria
* uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
* female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
* a prisoner

Where it's running

• University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Marlene Starr, PhD — University of Kentucky
• Study coordinator: Marlene Starr, PhD
• Email: marlene.starr@uky.edu
• Phone: 859-323-0471

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.