Clinical trial NCT06721507: 2024 Tirzepatide-Bariatric Surgery
Official title: Preoperative Tirzepatide for Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Obesity and Obesity-related Medical Conditions
Bariatric Surgery
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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
* BMI greater than or equal to 45 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
* have expressed preference and are deemed a suitable candidate for laparoscopic or robotic vertical sleeve gastrectomy
* enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

Exclusion Criteria:

* 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
* History of pancreatitis
* Type 1 Diabetes
* patients with active, untreated or symptomatic cholelithiasis or jaundice
* current use of a GLP-1 or GLP-1/GIP receptor agonist, or use within past 90 days
* a history of prior metabolic and bariatric surgery
* diagnosed autoimmune disease
* current use of immunosuppressive agents or use within the past 30 days
* moderate or severe substance use disorder according to DSM-5 criteria
* uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
* female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
* a prisoner

Primary outcomes:
measure: Change in inflammatory markers c reactive protein (CRP)
timeFrame: Baseline and 3 months post-drug
measure: Change in inflammatory markers interleukin 6 (IL-6)
timeFrame: Baseline and 3 months post-drug
measure: Change in inflammatory markers tumor necrosis factor (TNF)
timeFrame: Baseline and 3 months post-drug
measure: change in inflammatory markers (leptin)
timeFrame: Baseline and 3 months post-drug
measure: change in inflammatory markers (adiponectin)
timeFrame: Baseline and 3 months post-drug
measure: change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
timeFrame: Baseline and 3 months post-drug
measure: RNA sequencing
timeFrame: at time of surgery
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: 30-day surgical complications
timeFrame: 1-, 3-, 6-, and 12-months post surgery
measure: change in inflammatory markers c reactive protein (CRP)
timeFrame: 1-, 3-, 6-, and 12-months post surgery
measure: change in inflammatory markers interleukin 6 (IL-6)
timeFrame: 1-, 3-, 6-, and 12-months post surgery
measure: change in inflammatory markers tumor necrosis factor (TNF)
timeFrame: 1-, 3-, 6-, and 12-months post surgery
measure: change in inflammatory markers (leptin)
timeFrame: 1-, 3-, 6-, and 12-months post surgery
measure: change in inflammatory markers (adiponectin)
timeFrame: 1-, 3-, 6-, and 12-months post surgery
measure: change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)
timeFrame: 1-, 3-, 6-, and 12-months post surgery
measure: change in blood pressure
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: Change in Hemoglobin A1c
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: change in blood glucose
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: change in cholesterol
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: change in high-density lipoprotein (HDL)
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: change in low-density lipoprotein (LDL)
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: change in triglycerides
timeFrame: Baseline, 3 months post-drug, 1-, 3-, 6-, and 12-months post surgery
measure: change in insulin
timeFrame: Baseline, 3 months, post-drug, 1-, 6-, and 12-months post surgery
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Marlene Starr, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Varun Jain, MD
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: William B Inabnet, MD
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: Simon J Fisher, MD. PhD
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: Philip A Kern, MD
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: Barbara Nikolajczyk, PhD
role: STUDY_DIRECTOR
References: