RECRUITING

2024 Tirzepatide-Bariatric Surgery

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Obesity and Obesity-related Medical ConditionsBariatric Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Preoperative Tirzepatide for Bariatric Surgery

Quick Facts

Study Start:2025-02
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06721507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * BMI greater than or equal to 45 kg/m2 with one or more obesity-related comorbidities
  3. * have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
  4. * have expressed preference and are deemed a suitable candidate for laparoscopic or robotic vertical sleeve gastrectomy
  5. * enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
  1. * any contraindication to the use of tirzepatide (per package insert)
  2. * Personal or family history of medullary thyroid carcinoma
  3. * Patients with Multiple Endocrine Neoplasm syndrome type 2
  4. * Hypersensitivity to tirzepatide
  5. * History of pancreatitis
  6. * Type 1 Diabetes
  7. * patients with active, untreated or symptomatic cholelithiasis or jaundice
  8. * current use of a GLP-1 or GLP-1/GIP receptor agonist, or use within past 90 days
  9. * a history of prior metabolic and bariatric surgery
  10. * diagnosed autoimmune disease
  11. * current use of immunosuppressive agents or use within the past 30 days
  12. * moderate or severe substance use disorder according to DSM-5 criteria
  13. * uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
  14. * female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
  15. * a prisoner

Contacts and Locations

Study Contact

Marlene Starr, PhD
CONTACT
859-323-0471
marlene.starr@uky.edu
Varun Jain, MD
CONTACT
vja233@uky.edu

Principal Investigator

Marlene Starr, PhD
PRINCIPAL_INVESTIGATOR
University of Kentucky
Varun Jain, MD
STUDY_DIRECTOR
University of Kentucky
William B Inabnet, MD
STUDY_DIRECTOR
University of Kentucky
Simon J Fisher, MD. PhD
STUDY_DIRECTOR
University of Kentucky
Philip A Kern, MD
STUDY_DIRECTOR
University of Kentucky
Barbara Nikolajczyk, PhD
STUDY_DIRECTOR
University of Kentucky

Study Locations (Sites)

University of Kentucky
Lexington, Kentucky, 40506
United States

Collaborators and Investigators

Sponsor: Marlene Starr

  • Marlene Starr, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky
  • Varun Jain, MD, STUDY_DIRECTOR, University of Kentucky
  • William B Inabnet, MD, STUDY_DIRECTOR, University of Kentucky
  • Simon J Fisher, MD. PhD, STUDY_DIRECTOR, University of Kentucky
  • Philip A Kern, MD, STUDY_DIRECTOR, University of Kentucky
  • Barbara Nikolajczyk, PhD, STUDY_DIRECTOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-02
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity and Obesity-related Medical Conditions
  • Bariatric Surgery