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Completed

NCT Number: NCT02488057

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 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.

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Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

Active comparator. See arm descriptions.

Other names: Saxenda

Weight Loss

Behavioral

Active comparator. See arm descriptions.

Primary outcomes

  1. Beta Cell Function

    Time frame: 3 months

    disposition index: x10^-5min-1

Secondary outcomes

  1. Waist Circumference

    Time frame: 3 months

    inches

  2. Fasting Glucose

    Time frame: 3 months

    mg/dL

  3. Triglycerides

    Time frame: 3 months

    mg/dL

  4. HDL cholesterol

    Time frame: 3 months

    mg/dL

  5. Blood Pressure

    Time frame: 3 months

    mmHg

  6. Heart Sensitive C-reactive protein

    Time frame: 3 months

    hsCRP, mg/L

  7. Presence of genetic polymorphisms

    Time frame: 3 months

    yes or no

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2015
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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