Novel Type 2 Diabetes Mellitus Preventive Therapies

January 27, 2015 updated by: Boston Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glutamine + Lifestyle change
Glutamine 30 grams/day X 12-14 weeks, Lifestyle change
Drug: Glutamine (Pharmacological doses)
30 grams/day of glutamine for 12-14 months
Other Names:
  • NutreStore
Behavioral: Lifestyle change
Lifestyle change as recommended by Registered Dietitian
Placebo Comparator: No glutamine + Lifestyle change
Lifestyle change
Behavioral: Lifestyle change
Lifestyle change as recommended by Registered Dietitian

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 12-14 weeks
12-14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in A1C
Time Frame: 12-14 weeks
12-14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Investigators

  • Principal Investigator: Carine M Lenders, MD, ScD, MS, Physician Scientist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 27, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-27812 (K23DK082732)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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