Novel Type 2 Diabetes Mellitus Preventive Therapies
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      Because of recruitment difficulties the design was modified several times until April 2013
      when we were able to increase recruitment. The following changes were made from initial to
      final study design:

        1. Study moved from Clinical and Translational Science Institute (CTSI) to clinical setting
           (Nutrition and Fitness for Life Clinic)

        2. Ages eligible expanded from 12-19 years old to 12-19.9 years old

        3. Ethnicity/Race expanded from Hispanic only to include all races/ethnicities

        4. Patients without a past family history of T2DM were made eligible

        5. Study period was shortened from 6 months to 12-14 weeks

        6. Number of required visits were reduced from 5 visits to 3 visits (all of which took
           place during regularly scheduled clinic appointments)

        7. Open labeled but still randomized

        8. Those in the Glutamine arm were provided lifestyles change intervention

        9. Glycosylated hemoglobin (A1C) used instead of fasting Homeostatic Model
           Assessment-Insulin Resistance (HOMA-IR)

       10. Non-fasting blood draw rather than a fasting blood draw was instituted
    

Intervention name(s): Glutamine (Pharmacological doses); Lifestyle change
Intervention type(s): Drug; Behavioral
Intervention description(s): 30 grams/day of glutamine for 12-14 months; Lifestyle change as recommended by Registered Dietitian
Other intervention name(s): NutreStore
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention