2024 Tirzepatide-Bariatric Surgery

Launched by MARLENE STARR · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial, called the 2024 Tirzepatide-Bariatric Surgery study, is looking at whether taking a medication called tirzepatide before weight loss surgery can lead to better health outcomes after the surgery. Specifically, the study aims to see if tirzepatide can lower inflammation in the body and help with weight loss and other health issues, like diabetes and high blood pressure, after surgery. Participants will be divided into two groups: one group will take tirzepatide weekly for three months before their planned surgery, while the other group will not take the medication. Researchers will compare the results from both groups to understand the benefits of tirzepatide treatment.

To join this trial, participants must be adults scheduled for a specific type of weight loss surgery called laparoscopic or robotic sleeve gastrectomy and have a body mass index (BMI) of 45 or higher along with related health conditions. They will need to visit the clinic once a month for check-ups and to receive the medication, if assigned to that group. Participants will also keep a diary to track their medication use and any side effects. It’s important to note that certain health conditions and personal histories may prevent some people from participating in the study. Overall, this trial could help shape future treatments for obesity and improve surgical outcomes for many patients.

Gender

ALL

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