2024 Tirzepatide-Bariatric Surgery

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Marlene Starr
Study ID
NCT06721507
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bariatric Surgery
  • Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tirzepatide — DRUG
    Participants will be educated on dietary and lifestyle changes. Participants will self inject 2.5 mg tirzepatide subcutaneously once weekly and maintain a drug administration diary. Dose escalation will proceed per package directions if instructed by study team at follow up visits.
  • Standard of Care — BEHAVIORAL
    Participants will be educated on dietary and lifestyle changes

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Standard of Care plus Drug
    Participant receives drug for 3 months prior to surgery
  • Active Comparator: Standard of Care Alone

Primary Outcome Measure

Change in inflammatory markers c reactive protein (CRP) [ Time Frame: Baseline and 3 months post-drug ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506-

Find similar trials in Lexington, KY

By research site
University of Kentucky· Lexington, KY

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