Obesity and Obesity-related Medical Conditions
Conditions
Brief 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.
Interventions
DRUGMounjaro
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.
PROCEDURESleeve Gastrectomy
Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.
Sponsors
Nicholas Skertich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight Loss | 12 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type 2 Diabetes | 12 months after surgery | Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement. |
| High Blood Pressure | 12 months after surgery | — |
| Weight Loss | 18 months after surgery | — |
| Sleep Apnea | 12 months after surgery | Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N). |
| Complications/Side Effects | 12 months after surgery | — |
| High Cholesterol | 12 months after surgery | Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement. |
Countries
United States
Contacts
Primary ContactResearch Administrator
Outcome results
None listed