Grants and Contracts Details
Description
Excel Obesity Project 1 - Preoperative Glucagon-like peptide-1 Therapy in Bariatric Surgery Patients with Morbid Obesity (PreMO)
Background: Bariatric surgery is the most effective treatment modality for individuals with morbid obesity, providing significant and durable weight loss and co-morbidity resolution. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists have shown promise as weight loss drugs, in addition to their use in the treatment of metabolic disorders. While multimodal weight management is the standard of care for individuals with morbid obesity, the benefit of antecedent GLP-1 therapy prior to bariatric surgery has not been well-studied.
Objective: To conduct a clinical trial testing the hypothesis that preoperative treatment with a dual GLP-1/GIP receptor agonist enhances preoperative weight loss and 30 decreases tissue inflammation, resulting in improved postoperative outcomes.
Methods: We designed a randomized controlled trial (RCT) comparing preoperative treatment with tirzepatide versus standard medical care prior to sleeve gastrectomy with a target enrollment of fifty patients randomized 1:1. For three months preoperatively, the control arm will receive standard care in the form of dietary and lifestyle modification recommendations whereas the treatment arm will receive weekly tirzepatide, in addition to standard care. Blood is collected at enrollment through 12-months postoperatively and analyzed for inflammatory and metabolic markers. Tissues, (adipose, stomach, and liver) will be collected intraoperatively for transcriptome profiling and histological assessment.
Results: Ongoing trial with no reportable results.
Conclusions: Completion of this pilot RCT will provide data to support initiation of a larger RCT to determine therapeutic efficacy, and mechanisms of action, by which patients could benefit from preoperative treatment with tirzepatide.
Background: Bariatric surgery is the most effective treatment modality for individuals with morbid obesity, providing significant and durable weight loss and co-morbidity resolution. Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists have shown promise as weight loss drugs, in addition to their use in the treatment of metabolic disorders. While multimodal weight management is the standard of care for individuals with morbid obesity, the benefit of antecedent GLP-1 therapy prior to bariatric surgery has not been well-studied.
Objective: To conduct a clinical trial testing the hypothesis that preoperative treatment with a dual GLP-1/GIP receptor agonist enhances preoperative weight loss and 30 decreases tissue inflammation, resulting in improved postoperative outcomes.
Methods: We designed a randomized controlled trial (RCT) comparing preoperative treatment with tirzepatide versus standard medical care prior to sleeve gastrectomy with a target enrollment of fifty patients randomized 1:1. For three months preoperatively, the control arm will receive standard care in the form of dietary and lifestyle modification recommendations whereas the treatment arm will receive weekly tirzepatide, in addition to standard care. Blood is collected at enrollment through 12-months postoperatively and analyzed for inflammatory and metabolic markers. Tissues, (adipose, stomach, and liver) will be collected intraoperatively for transcriptome profiling and histological assessment.
Results: Ongoing trial with no reportable results.
Conclusions: Completion of this pilot RCT will provide data to support initiation of a larger RCT to determine therapeutic efficacy, and mechanisms of action, by which patients could benefit from preoperative treatment with tirzepatide.
Key findings
none available
| Short title | GLP-1 therapy prior to bariatric surgery |
|---|---|
| Acronym | PreMO |
| Status | Active |
| Effective start/end date | 7/1/24 → 5/31/26 |
Funding
- University of Kentucky Diabetes and Obesity Research Priority Area
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