2024 Tirzepatide-Bariatric Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarlene Starr
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
tirzepatide
DrugParticipants 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
BehavioralParticipants will be educated on dietary and lifestyle changes
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Standard of Care plus DrugExperimental treatment 1 intervention
Group B: Standard of Care AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in inflammatory markers c reactive protein (CRP)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame
Baseline and 3 months post-drug2
Change in inflammatory markers interleukin 6 (IL-6)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame
Baseline and 3 months post-drug3
Change in inflammatory markers tumor necrosis factor (TNF)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame
Baseline and 3 months post-drug4
change in inflammatory markers (leptin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame
Baseline and 3 months post-drugSecondary outcomes
1
Change in weight
patient weight will be measured
Time frame
Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery2
30-day surgical complications
Surgical complications will be assessed as standard of care and data evaluated for this study
Time frame
1-,6-, and 12-months post surgery3
change in inflammatory markers c reactive protein (CRP)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame
1-, 6-, and 12-months post surgery4
change in inflammatory markers interleukin 6 (IL-6)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame
1-, 6-, and 12-months post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Marlene Starr
Lead sponsor
University of Kentucky
Sponsor institution
Source ClinicalTrials.gov