A Phase 1 interventional study of Glutamine (Pharmacological doses) and Lifestyle change in Diabetes, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2015-01-30.
Sponsored by Boston Medical Center · Phase 1, Interventional, and Prevention
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.
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:
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Boston Medical Center is the lead sponsor of 314 studies on the registry; 34 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
9 .Use of illegal/illicit drugs;
Glutamine 30 grams/day X 12-14 weeks, Lifestyle change
Drug: Glutamine (Pharmacological doses) · Behavioral: Lifestyle change
Lifestyle change
Behavioral: Lifestyle change
30 grams/day of glutamine for 12-14 months
Also known as: NutreStore
Lifestyle change as recommended by Registered Dietitian
Weight gain
Time frame: 12-14 weeks
Change in A1C
Time frame: 12-14 weeks
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Boston Medical Center