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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: Completed Phase 4 study, sponsored by Ohio State University.

NCT02488057 is a Phase 4 study that has completed, run by Ohio State University. The registered enrollment target is 360 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

disposition index: x10\^-5min-1

Interventions

  • DRUG Liraglutide
  • BEHAVIORAL Weight loss

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2016-05
Est. Completion 2019-03
Phase Phase 4
Ohio State University

552 total trials

What the finished NCT02488057 record still lists

NCT02488057 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (31% lower).

The record links to 0 conditions, and to 2 interventions - of which Liraglutide is the first listed.

NCT02488057 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02488057's enrollment target sits among peer trials

360 225th of 2000 higher than 1,775 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02488057, the US trial registry maintained by the National Library of Medicine. NCT02488057 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.