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NCT02488057 · ClinicalTrials.gov registry record · Phase 4
Improving Beta Cell Function in Mexican American Women With Prediabetes
A Phase 4 study, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 360
- Enrollment target
NCT02488057 is a Phase 4 study that has completed, run by Ohio State University. The registered enrollment target is 360 participants.
The verdict
NCT02488057, a Phase 4 study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 360 participants
- Enrollment target
Study Summary
This study will examine the benefits of weight loss alone or in combination with a GLP1 receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA) women with prediabetes. The Investigators have chosen to focus on MA women because MA women are at very high risk for progression to diabetes and have not traditionally been involved in weight management studies since they are thought to be difficult to recruit and retain in such programs. However, investigators have had particular success in working with young MA women using specifically developed ethnic and gender conscious programs. Because weight loss does not prevent all progression to diabetes, some participants will receive the diabetes medication, liraglutide, which has been shown to stabilize beta cell function. The study will also interrogate for polymorphisms of known T2DM genes to correlate with beta cell response to weight loss and liraglutide treatment. Additionally, this investigation targets serious health disparities in metabolic disease in a highly vulnerable, rapidly growing population, testing novel gender and culturally focused intervention strategies and identifying genetic biomarkers of response to a pharmacologic intervention that targets the pancreatic ßcell. These results will help to a) understand mechanisms of disease, b) personalize treatment through identification of a high risk group that may be amenable to specific therapy, and c) ultimately, sets the stage for an intervention trial to prevent diabetes, a major chronic and costly disease, in Mexican Americans.
Interventions
- DRUG Liraglutide
- BEHAVIORAL Weight loss
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2016-05 |
| Est. Completion | 2019-03 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02488057
The ClinicalTrials.gov registry entry for NCT02488057 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liraglutide is the first listed.
NCT02488057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02488057 about?
NCT02488057 is a clinical study titled "Improving Beta Cell Function in Mexican American Women With Prediabetes". This study will examine the benefits of weight loss alone or in combination with a GLP1 receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA) women with prediabetes. The Investigators have chosen to focus on MA women because MA women are at very high risk for prog...
What is the current status of trial NCT02488057?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 360 participants. The study started on 2016-05. Estimated completion is 2019-03.
What interventions are being tested in trial NCT02488057?
The interventions under investigation include: Liraglutide (DRUG), Weight loss (BEHAVIORAL).
Who is sponsoring clinical trial NCT02488057?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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