Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss
Nicholas Skertich
42 participants
Mar 10, 2025
INTERVENTIONAL
Conditions
Summary
This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.
Eligibility
Inclusion Criteria3
- Adult 18 to 65 years of age
- Body Mass Index >35 with comorbidity of Type 2 Diabetes and/or Hypertension and/or Hyperlipidemia and/or Obstructive Sleep Apnea OR Body Mass Index >40 with or without comorbidity
- Undergoing primary sleeve gastrectomy
Exclusion Criteria14
- Prior metabolic and bariatric surgery
- Prior use of GLP-1 agonist
- Prior history of pancreatitis
- Personal/family history of medullary thyroid cancer or MEN type 2
- Secondary cause of obesity
- Any eating disorder
- Pregnancy/lactation
- History of acute coronary syndrome or myocardial infarction
- History of stroke
- Hepatic dysfunction: AST/ALT >3 ULN
- Renal dysfunction eGFR<45ml/min/1.73m2
- Active malignancy
- History of diabetic retinopathy
- History of gastroparesis
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Interventions
In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide after surgery. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery.
Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06734273