Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss
NCT ID: NCT06734273
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
42 participants
INTERVENTIONAL
2025-03-10
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SG-T: sleeve gastrectomy with tirzepatide
In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery 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.
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.
Sleeve Gastrectomy
Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
SG-A: sleeve gastrectomy alone
In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.
Sleeve Gastrectomy
Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
Interventions
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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.
Sleeve Gastrectomy
Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Nicholas Skertich
OTHER
Responsible Party
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Nicholas Skertich
Assistant Professor
Principal Investigators
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Nicholas Skertich, MD
Role: PRINCIPAL_INVESTIGATOR
Rush University Medical Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24101008
Identifier Type: -
Identifier Source: org_study_id
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