Improving Beta Cell Function in Mexican American Women With Prediabetes



Status:Recruiting
Conditions:Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 40
Updated:4/17/2018
Start Date:May 2016
End Date:September 2020
Contact:Evangelina T Villagomez, PhD
Email:evangelina.villagomez@osumc.edu
Phone:346-206-8867

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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.

Investigators will test the hypothesis that liraglutide, because of its actions on the
β-cell, will amplify the effects of lifestyle management to improve β-cell function.
Investigators will recruit MA ages 18-40, since above this age the incidence of T2DM in obese
MA women in our experience approaches 50%. The primary endpoint will be β-cell function
(AIRg) in response to lifestyle change with and without GLP-1 agonist at 3 months. Secondary
endpoints will be reversal of metabolic syndrome and changes in plasma biomarkers. By the end
of 3 months, the prediabetic subject will be in the best possible metabolic control, and
investigators would predict that the liraglutide group would reveal better β-cell function.
Thus, data from this time point will be used for pharmacogenetic studies. The program will be
continued for 3 more months for transition to regular healthy meals with the goal of weight
maintenance. During this second 3 months, subjects will be off liraglutide to determine the
sustainability of the improved β-cell function. In the absence of weight re-gain,
investigators predict that the intensive weight loss alone group would maintain improved
β-cell function, but the intensive weight loss+liraglutide group would display even better
function. These results will provide useful information about improving β-cell function in
the management of young women with pre-diabetes.

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
We found this trial at
4
sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-423-1424
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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7037 Capitol Street
Houston, Texas 77011
Phone: 832-395-0912
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Houston, Texas 77020
Phone: 832-395-0909
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Torrance, California 90502
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