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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Participants will be educated on dietary and lifestyle changes
University of Kentucky
Lexington, Kentucky, United States
RECRUITINGChange 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-drug
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-drug
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-drug
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-drug
change in inflammatory markers (adiponectin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame: Baseline and 3 months post-drug
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
Inflammatory markers will be measured by ELISA in blood samples drawn from patient.
Time frame: Baseline and 3 months post-drug
RNA sequencing
Bulk RNA sequencing analyses will be performed on tissue samples of fat and liver collected at the time of surgery
Time frame: at time of surgery
Change in weight
patient weight will be measured
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
30-day surgical complications
Surgical complications will be assessed as standard of care and data evaluated for this study
Time frame: 1-, 3-, 6-, and 12-months post surgery
change in inflammatory markers c reactive protein (CRP)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame: 1-, 3-, 6-, and 12-months post surgery
change in inflammatory markers interleukin 6 (IL-6)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame: 1-, 3-, 6-, and 12-months post surgery
change in inflammatory markers tumor necrosis factor (TNF)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame: 1-, 3-, 6-, and 12-months post surgery
change in inflammatory markers (leptin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame: 1-, 3-, 6-, and 12-months post surgery
change in inflammatory markers (adiponectin)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame: 1-, 3-, 6-, and 12-months post surgery
change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Time frame: 1-, 3-, 6-, and 12-months post surgery
change in blood pressure
blood pressure per standard method in clinic
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
Change in Hemoglobin A1c
HbA1c will be measured by clinic lab
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
change in blood glucose
blood glucose will me measured in clinic lab
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
change in cholesterol
cholesterol measured in clinic lab
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
change in high-density lipoprotein (HDL)
high-density lipoprotein (HDL) measured in clinic lab
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
change in low-density lipoprotein (LDL)
low-density lipoprotein measured by clinic lab
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
change in triglycerides
triglycerides measured in clinic lab
Time frame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
change in insulin
insulin measured in clinic lab
Time frame: Baseline, 3 months, post-drug, 1-, 6-, and 12-months post surgery
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