Novel Type 2 Diabetes Mellitus Preventive Therapies
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
Over the past two decades, type 2 diabetes mellitus (T2DM) has emerged from relative
obscurity to become one of the most serious complications of obesity in Hispanic obese
populations, especially among those with a family history of T2DM. Few therapies have
demonstrated long term efficacy in combating obesity and risk of T2DM in youth. Given the
emerging evidence that glutamine and leucine (building blocks of protein) may affect energy
partition and thus diabetes risk, and that the relationship of glutamine and diabetic risk
has been further evaluated in one adult observational cohort study but data on leucine are
lacking, we plan to conduct a clinical trial to determine the efficacy of glutamine to reduce
insulin resistance, a diabetes risk factor.
The primary specific aim of the research plan is to conduct a randomized, double-blind,
placebo controlled, clinical trial to test the efficacy of 6 months supplements of glutamine
in reducing biomarkers for insulin resistance and weight gain among 56 obese Hispanic
adolescents age 12-19 years with a BMI at or above the 95th percentile and a family history
of T2DM. At the end of the grant period, we will have obtained preliminary data to plan
pivotal clinical trials of glutamine coupled with or without lifestyle changes.