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Novel Type 2 Diabetes Mellitus Preventive Therapies

NCT ID: NCT02351323

Last Updated: 2015-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-08-31

Brief Summary

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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

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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

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Glutamine + Lifestyle change

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

Group Type EXPERIMENTAL

Glutamine (Pharmacological doses)

Intervention Type DRUG

30 grams/day of glutamine for 12-14 months

Lifestyle change

Intervention Type BEHAVIORAL

Lifestyle change as recommended by Registered Dietitian

No glutamine + Lifestyle change

Lifestyle change

Group Type PLACEBO_COMPARATOR

Lifestyle change

Intervention Type BEHAVIORAL

Lifestyle change as recommended by Registered Dietitian

Interventions

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Glutamine (Pharmacological doses)

30 grams/day of glutamine for 12-14 months

Intervention Type DRUG

Lifestyle change

Lifestyle change as recommended by Registered Dietitian

Intervention Type BEHAVIORAL

Other Intervention Names

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NutreStore

Eligibility Criteria

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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

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;

10\. Unable to comply with the protocol;

11\. Any other serious disease determined by the clinician as potential study risk for the patient.

12\. Have kidney or liver disorders, or conditions resulting in ammonia accumulation

13\. Take Lactulose

14\. Are allergic to monosodium glutamate (MSG), glutamine, or Crystal Light

15\. Have manic episodes (mental illness)

16\. Take medications to prevent seizures

17\. Take any glutamine, supplement with glutamine, hypoglycemiants, anticonvulsivant, ADHD medications, antilipidemiants, or thyroid hormone

18\. 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carine M Lenders, MD, ScD, MS

Role: PRINCIPAL_INVESTIGATOR

Physician Scientist

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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H-27812 (K23DK082732)

Identifier Type: -

Identifier Source: org_study_id