Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNicholas Skertich
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mounjaro
DrugIn 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
Procedure/SurgerySubjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: SG-T: sleeve gastrectomy with tirzepatideExperimental treatment 2 interventions
Group B: SG-A: sleeve gastrectomy aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Weight Loss
Time frame
12 months after surgerySecondary outcomes
1
Weight Loss
Time frame
18 months after surgery2
Type 2 Diabetes
Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.
Time frame
12 months after surgery3
Type 2 Diabetes
Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.
Time frame
18 months after surgery4
High Blood Pressure
Time frame
12 months after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Nicholas Skertich
Lead sponsor
Rush University Medical Center
Sponsor institution
Source ClinicalTrials.gov