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Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss

RECRUITINGEarly 1Sponsored by Nicholas Skertich
Actively Recruiting
PhaseEarly 1
SponsorNicholas Skertich
Started2025-03-10
Est. completion2027-03
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06734273

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

Age: 18 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions2

Obesity and Obesity-related Medical ConditionsWeight Loss

Locations1 site

Rush University Medical Center
Chicago, Illinois, 60612
Sr. Clinical Research Coordinator312-942-5500matthew_johnson@rush.edu

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