Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy (MDB-GLN)

December 20, 2007 updated by: Assistance Publique - Hôpitaux de Paris

Efficacy Study of Oral Glutamine Supplementation in Duchenne Muscular Dystrophy

The purpose of this study is to determine whether long-term oral glutamine supplementation is effective in improving muscle mass and function in children with Duchenne muscular dystrophy (DMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glutamine inhibits whole body protein degradation in children with Duchenne Muscular Dystrophy (DMD). The effect is observed after 5 h oral glutamine administration and is also found when glutamine is given over a 10-day period. This multi-site national study aims to evaluate the functional benefit of long-term oral glutamine administration in 30 DMD children using a randomized double-blind placebo-controlled cross-over design. The study includes two 4-month periods: 1) a treatment period in which the subject receives oral glutamine (0.5 g/kg/d) and 2) a control period in which the subject receives a placebo. The order of treatment allocation is randomized. The two 4-month periods are separated by a 1 month wash-out period. The children are monitored every 2 months during period 1 (M0, M2, M4) and period 2 (M5, M7, M9) in the clinical investigation centres of Hospital Robert Debré in Paris and the CHR&U de Lille, as well as the clinical research centre of the CHU de Poitiers. Evidence of a functional benefit would involve evaluating the administration of glutamine over longer periods (as early as possible following diagnosis) among severely handicapped children and in other chronic pathologies associated with increased muscle protein catabolism. In DMD, such evidence would enable children to undergo gene therapy under improved physical condition.

Comparisons: Glutamine administration compared to placebo on the following outcome measures: walking speed on a standard course, work (kcal) and power (kcal/s) in relation to effort, body composition (bioelectrical impedance analysis and BIPHOTONIC absorptiometry), muscle mass (24-h urinary creatinine excretion), indices of protein degradation (CPK and 3-methyl histidine excretion) and biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BPI).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

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

  • France
      • Lille, France, 59037
        • Centre d'Investigation Clinique, Hôpital Cardiologique, CHR&U de Lille
      • Lille, France, 59037
        • Service d'Hépato Gastro Entérologie, Hôpital Jeanne de Flandre, CHR&U de Lille
      • Lille, France, 59037
        • Service de Neuropédiatrie, Hôpital Roger Salengro, CHR&U de Lille
      • Paris, France, 75935
        • Centre d'Investigation Clinique (CIC9202), Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris
      • Poitiers, France, 86000
        • Pédiatrie Multidisciplinaire et Nutrition de l'Enfant, Centre Hospitalier Universitaire de Poitiers

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Clinical diagnosis of Duchenne muscular dystrophy
  • Able to walk >170 m
  • Absence of hepatic insufficiency
  • Absence of renal insufficiency

Exclusion Criteria:

  • Dependent upon wheelchair
  • Body weight >60kg
  • Liver failure
  • Kidney failure
  • Surgery scheduled during the year following the first visit

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: L-Glutamine
L-Glutamine
Placebo Comparator: 2
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
walking speed at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
work (kcal) at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months
power (kcal/s) at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months
2-minute walk test at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months
body composition (bioelectrical impedance analysis) at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months
body composition (BIPHOTONIC absorptiometry) at 4,9 months
Time Frame: at 4,9 months
at 4,9 months
muscle mass (24-h urinary creatinine excretion) at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months
indices of protein degradation (CPK and 3-methyl histidine excretion) at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months
biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BP3) at 0,2,4,5,7,9 months
Time Frame: at 0,2,4,5,7,9 months
at 0,2,4,5,7,9 months

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Régis Hankard, MD, PhD, Centre Hospitalier Universitaire (CHU) de Poitiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2006

Primary Completion (Anticipated)

February 1, 2008

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 27, 2006

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 20, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P030420
  • AOM 03 121

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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