Novel Type 2 Diabetes Mellitus Preventive Therapies

Diabetes Clinical Trial

Official title: Novel Type 2 Diabetes Mellitus Preventive Therapies

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

• NCT number: NCT02351323
• Study type: Interventional
• Source: Boston Medical Center
• Status: Completed
• Phase: Phase 1
• Start date: May 2010
• Completion date: August 2014