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CompletedNCT02351323Updated Jan 30, 2015

Novel Type 2 Diabetes Mellitus Preventive Therapies

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

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
12 Years to 19 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

03

In context

Diabetes Mellitus

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. BMI (k/m2) >= 95th percentile;
  2. Weight 150 - 400 pounds;
  3. Language: English or Spanish (The PI speaks both English and Spanish fluently).

Exclusion criteria

Exclusion Criteria:

  1. History of T2DM;
  2. Prior or current drug treatmeant that would effect diabetes risk
  3. Use of prescription strength glucocorticoids within three months before screening,
  4. History of syndrome or medical disorder associated with significant obesity;
  5. Serum creatinine >1.2 mg/dL;
  6. Alanine transaminase (ALT) or Aspartate aminotransferase (AST) >90 international units (IU)/L (= 3 X normal limits);
  7. Total bilirubin >2.5 time the upper limit of normal;
  8. History of moderate to extreme physical activity, past or current pregnancy;

9 .Use of illegal/illicit drugs;

  1. Unable to comply with the protocol;
  1. Any other serious disease determined by the clinician as potential study risk for the patient.
  1. Have kidney or liver disorders, or conditions resulting in ammonia accumulation
  1. Take Lactulose
  1. Are allergic to monosodium glutamate (MSG), glutamine, or Crystal Light
  1. Have manic episodes (mental illness)
  1. Take medications to prevent seizures
  1. Take any glutamine, supplement with glutamine, hypoglycemiants, anticonvulsivant, ADHD medications, antilipidemiants, or thyroid hormone
  1. Participation in a weight loss program or use of weight loss medications within six months of screening that has resulted in 5% or more weight loss
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Glutamine + Lifestyle change

    Glutamine 30 grams/day X 12-14 weeks, Lifestyle change

    Drug: Glutamine (Pharmacological doses) · Behavioral: Lifestyle change

  • Placebo comparator
    No glutamine + Lifestyle change

    Lifestyle change

    Behavioral: Lifestyle change

Interventions

  • DrugGlutamine (Pharmacological doses)

    30 grams/day of glutamine for 12-14 months

    Also known as: NutreStore

  • BehavioralLifestyle change

    Lifestyle change as recommended by Registered Dietitian

06

What researchers measure

Primary outcomes

  1. Weight gain

    Time frame: 12-14 weeks

Secondary outcomes

  1. Change in A1C

    Time frame: 12-14 weeks

07

Study locations

1 site
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02351323
Lead sponsor
Boston Medical Center
Responsible party
Sponsor
First posted
Jan 30, 2015
Start date
May 2010
Primary completion
Aug 2014
Completion
Aug 2014
Last update
Jan 30, 2015

Study contacts

Carine M Lenders, MD, ScD, MS
principal investigator · Physician Scientist

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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