Improving Beta Cell Function in Mexican American Women With Prediabetes

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Mexican-american

• Female

• BMI 30-42

• willingness to complete protocol

• pre-diabetic

• English or Spanish literate

Exclusion Criteria:

• pregnant

• 30 min or more of moderate to vigorous activity more than 3 times per week

• cardiovascular disease

• physical limitations that might be aggravated by moderate physical activity

• planning to move in next 12-24 months

• diabetic