NCT02351323

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started May 2010

Longer than P75 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

4.3 years

First QC Date

December 17, 2014

Last Update Submit

January 27, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    12-14 weeks

Secondary Outcomes (1)

  • Change in A1C

    12-14 weeks

Study Arms (2)

Glutamine + Lifestyle change

EXPERIMENTAL

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

Drug: Glutamine (Pharmacological doses)Behavioral: Lifestyle change

No glutamine + Lifestyle change

PLACEBO COMPARATOR

Lifestyle change

Behavioral: Lifestyle change

Interventions

Glutamine (Pharmacological doses)DRUG

30 grams/day of glutamine for 12-14 months

Also known as: NutreStore
Glutamine + Lifestyle change
Lifestyle changeBEHAVIORAL

Lifestyle change as recommended by Registered Dietitian

Glutamine + Lifestyle changeNo glutamine + Lifestyle change

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • History of T2DM;
  • Prior or current drug treatmeant that would effect diabetes risk
  • Use of prescription strength glucocorticoids within three months before screening,
  • History of syndrome or medical disorder associated with significant obesity;
  • Serum creatinine \>1.2 mg/dL;
  • Alanine transaminase (ALT) or Aspartate aminotransferase (AST) \>90 international units (IU)/L (= 3 X normal limits);
  • Total bilirubin \>2.5 time the upper limit of normal;
  • History of moderate to extreme physical activity, past or current pregnancy;
  • Use of illegal/illicit drugs;
  • \. Unable to comply with the protocol;
  • \. Any other serious disease determined by the clinician as potential study risk for the patient.
  • \. Have kidney or liver disorders, or conditions resulting in ammonia accumulation
  • \. Take Lactulose
  • \. Are allergic to monosodium glutamate (MSG), glutamine, or Crystal Light
  • \. Have manic episodes (mental illness)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Carine M Lenders, MD, ScD, MS

    Physician Scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

January 30, 2015

Study Start

May 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

US(1)