Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mounjaro, Sleeve Gastrectomy.
- Who it may be relevant to
- Registry conditions: Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Mounjaro
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. - Procedure Sleeve Gastrectomy
Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
Primary outcome measures
- Weight Loss [Time frame: 12 months after surgery]
Secondary outcome measures (11)
- Weight Loss [Time frame: 18 months after surgery]
- Type 2 Diabetes [Time frame: 12 months after surgery]
- Type 2 Diabetes [Time frame: 18 months after surgery]
- High Blood Pressure [Time frame: 12 months after surgery]
- High Blood Pressure [Time frame: 18 months after surgery]
- High Cholesterol [Time frame: 12 months after surgery]
- High Cholesterol [Time frame: 18 months after surgery]
- Sleep Apnea [Time frame: 12 months after surgery]
- Sleep Apnea [Time frame: 18 months after surgery]
- Complications/Side Effects [Time frame: 12 months after surgery]
- Complications/Side Effects [Time frame: 18 months after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Rush University Medical Center — Chicago
Identifiers
NCT: NCT06734273 · 24101008