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2024 Tirzepatide-Bariatric Surgery

RecruitingPhase 4Ages 18 Years - anyAllMarlene Starr
NCT06721507 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 n

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📋 Eligibility rules (as published)
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
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What it tests

  • tirzepatide
  • Standard of Care
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Where

1 site
University of Kentucky
Lexington, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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