2024 Tirzepatide-Bariatric Surgery

StatusRecruiting
PhasePhase 4
Started

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Record History

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  1. Minor Secondary endpoints: details revised at 16 of 16 entriesv7
  2. Minor Eligibility criteria shortened, about 21 wordsv6
  3. Minor Start date changed from estimate of Apr 2025 to Mar 27, 2025v5
  4. Notable Start date: Feb 2025 to Apr 2025v4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2025 to Feb 2025
    • Site details revised
    v3
  6. Minor Start date: Dec 2024 to Jan 2025v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06721507
Lead Sponsor Marlene Starr
Conditions
(from sponsor)
Obesity and Obesity-related Medical Conditions, Bariatric Surgery
Related terms Obesity
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov