Improving Beta Cell Function in Mexican American Women With Prediabetes
Condition: Pre-Diabetes
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Liraglutide; Weight loss
Intervention type(s): Drug; Behavioral
Intervention description(s): Active comparator. See arm descriptions.; Active comparator. See arm descriptions.
Other intervention name(s): Saxenda
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention