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Randomized Control Trial of Sleeve Gastrectomy with Tirzepatide in Maximizing Weight Loss
Phase < 1
Waitlist Available
Led By Nicholas Skertich, MD
Research Sponsored by Nicholas Skertich
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months after surgery
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Obesity
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months after surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
High Cholesterol
Sleep Apnea
Type 2 Diabetes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SG-T: sleeve gastrectomy with tirzepatideExperimental Treatment2 Interventions
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.
Group II: SG-A: sleeve gastrectomy aloneActive Control1 Intervention
In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleeve Gastrectomy
2018
Completed Phase 3
~2290
Find a Location
Who is running the clinical trial?
Nicholas SkertichLead Sponsor
Nicholas Skertich, MDPrincipal InvestigatorRush University Medical Center