CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 360 enrolled
Drug / intervention
Liraglutide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02488057
NCT02488057Phase 4Completed

Improving Beta Cell Function in Mexican American Women With Prediabetes

Ohio State University·interventional·Posted Jul 2, 2015·Updated Aug 28, 2019

In Brief

A Phase 4 clinical trial evaluating Liraglutide and Weight loss for Pre-Diabetes. Completed, enrolled 360 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre-Diabetes
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2, 2015
Enrollment StartMay 1, 2016
Primary CompletionMar 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11 years ago

Interventions

Liraglutidedrug

Active comparator. See arm descriptions.

Weight lossbehavioral

Active comparator. See arm descriptions.