GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Feasibility Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with severe obesity (BMI > 50) 3 months after bariatric surgery (Roux-en-Y Gastric Bypass). We also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 3 months after bariatric surgery will be compared to patients who undergo surgery only.

Official Title
-----------------
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Feasibility Trial

Conditions
-----------------
Severe Obesity

Intervention / Treatment
-----------------
* Drug: Tirzepatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be able to understand and provide informed consent. BMI > 50 at time of bariatric surgery Age > 30 and < 65 Patients undergoing primary Roux-en-Y Gastric Bypass Exclusion Criteria: Inability or unwillingness of a subject to give written informed consent or comply with the study protocol. Diagnosis of type I Diabetes Revisional bariatric surgery (prior adjustable gastric band, sleeve gastric, vertical banded gastroplasty). Use of antidiabetic agent, other than metformin, including GLP-1R agonist in the previous 90 days. Metformin is allowed provided the dose has been stable in the 90 days prior to screening and will remain stable for the duration of the trial. Patient-reported Tobacco, e-cigarette, or smoked marijuana use within 12 months As this would preclude patients from undergoing bariatric surgery. Personal history of pancreatitis as determined by history. Personal or family history of medullary thyroid cancer by history or multiple endocrine neoplasia syndrome type 2 Pregnancy by urine testing, current lactation, or plans to become pregnant during the study period. Use of systemic glucocorticoids in the past 28 days Myocardial infarction, unstable angina, stroke, or heart failure (NYHA class II) within 1 year by history. History of solid organ transplant. History of physician-diagnosed malignancy (other than excised non-melanoma skin cancer) in the past 5 years. Current uncontrolled hypertension (systolic >150, diastolic >90) or untreated hyperthyroidism. Current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements. Screening creatinine elevation with EGFR < 60 at time of randomization.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide Group<br>Patients will receive Tirzepatide beginning 3 months after undergoing Roux-en-Y Gastric Bypass following the standard Tirzepatide titration to a maximum dose of 15 mg weekly. | Drug: Tirzepatide<br>* Tirzepatide will be initiated 3 months after patients undergo Roux-en-Y Gastric Bypass. Patients will be started on the lowest dose of 2.5 mg and the dose increased every 4 weeks until the maximum 15 mg dose or the maximum tolerated dose is achieved. Patients will then complete a final 4 weeks of the study drug.<br>* Other names: Mounjaro;|
| No Intervention: Observation<br>Patients in the observation group will undergo the same testing as the Tirzepatide group but will not receive any study drug. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Change in weight over time. | 24 weeks | 
| Gastrointestinal symptoms | Gastroparesis Cardinal Symptom Index | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, Roux-en-Y Gastric Bypass, GLP-1 Receptor Agonists, Tirzepatide