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NCT06132477 · ClinicalTrials.gov registry record · Phase 4
Impact GLP-1 Agonists Following Bariatric
A Phase 4 study of Hypertension and Diabetes Mellitus, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06132477 is a Phase 4 study of Hypertension and Diabetes Mellitus that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 150 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06132477, a Phase 4 study of Hypertension and Diabetes Mellitus, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those
Conditions Studied
Interventions
- DRUG GLP-1 receptor agonist
Study Locations (1)
Missouri
- University of Missouri Hospital - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2030-07 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06132477
The ClinicalTrials.gov registry entry for NCT06132477 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (96% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which GLP-1 receptor agonist is the first listed.
NCT06132477 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT06132477 about?
NCT06132477 is a clinical study titled "Impact GLP-1 Agonists Following Bariatric". Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown...
What is the current status of trial NCT06132477?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2024-02-01. Estimated completion is 2030-07.
What conditions does trial NCT06132477 study?
This clinical trial studies the following conditions: Hypertension, Diabetes Mellitus, Metabolic Syndrome, Morbid Obesity, Obstructive Sleep Apnea of Adult.
What interventions are being tested in trial NCT06132477?
The interventions under investigation include: GLP-1 receptor agonist (DRUG).
Who is sponsoring clinical trial NCT06132477?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06132477 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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