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Muscular Dystrophy, DuchennePhase 2MDB-GLNNCT00296621

Effect of Oral Glutamine on Muscle Mass and Function in Duchenne Muscular Dystrophy

A Phase 2 study testing L-Glutamine in people with Muscular Dystrophy, Duchenne, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Any age, men only
Conditions the study is for
Muscular Dystrophy, Duchenne
What is being tested?
L-Glutamine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
5 sitesFrance
Study dates
Feb 2006to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • Centre d'Investigation Clinique, Hôpital Cardiologique, CHR&U de Lille

    Lille, 59037

  • Service d'Hépato Gastro Entérologie, Hôpital Jeanne de Flandre, CHR&U de Lille

    Lille, 59037

  • Service de Neuropédiatrie, Hôpital Roger Salengro, CHR&U de Lille

    Lille, 59037

  • Centre d'Investigation Clinique (CIC9202), Hôpital Robert Debré, Assistance Publique-Hôpitaux de Paris

    Paris, 75935

  • Pédiatrie Multidisciplinaire et Nutrition de l'Enfant, Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000

Other trials in France

About this study

Official title: 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).

Read the 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).

Being tested
L-Glutamine, placebo
Keywords
glutamine, nutrition, children, pediatrics, randomized controlled clinical trial, therapy, supplement, oral administration, handicap
Medical subject headings
Muscular Dystrophy, Duchenne

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L-GlutamineDrug

    L-Glutamine

  • placeboDrug

    placebo

Study groups in NCT00296621
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: L-Glutamine
2Placebo comparatorNot described
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. walking speed at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

Secondary outcomes (8)

  1. work (kcal) at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

  2. power (kcal/s) at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

  3. 2-minute walk test at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

  4. body composition (bioelectrical impedance analysis) at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

  5. body composition (BIPHOTONIC absorptiometry) at 4,9 months

    Measured: at 4,9 months

  6. muscle mass (24-h urinary creatinine excretion) at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

  7. indices of protein degradation (CPK and 3-methyl histidine excretion) at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

  8. biochemical parameters (electrolytes, fasting glucose, transaminases, insulin, IgfI, Igf-BP3) at 0,2,4,5,7,9 months

    Measured: at 0,2,4,5,7,9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionFeb 2008 (estimated)
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00296621
Sponsor's protocol ID
P030420
Other IDs
AOM 03 121
Acronym
MDB-GLN
Status last verified
Dec 2007
First submitted
23 Feb 2006
Last updated
21 Dec 2007
Results posted
No
Data monitoring committee
No

Publications

  • Mok E, Eleouet-Da Violante C, Daubrosse C, Gottrand F, Rigal O, Fontan JE, Cuisset JM, Guilhot J, Hankard R. Oral glutamine and amino acid supplementation inhibit whole-body protein degradation in children with Duchenne muscular dystrophy. Am J Clin Nutr. 2006 Apr;83(4):823-8. doi: 10.1093/ajcn/83.4.823.

    PubMed 16600934

  • Hankard R, Mauras N, Hammond D, Haymond M, Darmaun D. Is glutamine a 'conditionally essential' amino acid in Duchenne muscular dystrophy? Clin Nutr. 1999 Dec;18(6):365-9. doi: 10.1016/s0261-5614(99)80017-x.

    PubMed 10634922

  • Hankard RG, Hammond D, Haymond MW, Darmaun D. Oral glutamine slows down whole body protein breakdown in Duchenne muscular dystrophy. Pediatr Res. 1998 Feb;43(2):222-6. doi: 10.1203/00006450-199802000-00011.

    PubMed 9475288

  • Hankard RG, Haymond MW, Darmaun D. Effect of glutamine on leucine metabolism in humans. Am J Physiol. 1996 Oct;271(4 Pt 1):E748-54. doi: 10.1152/ajpendo.1996.271.4.E748.

    PubMed 8897864

  • Hankard RG, Darmaun D, Sager BK, D'Amore D, Parsons WR, Haymond M. Response of glutamine metabolism to exogenous glutamine in humans. Am J Physiol. 1995 Oct;269(4 Pt 1):E663-70. doi: 10.1152/ajpendo.1995.269.4.E663.

    PubMed 7485479

  • Mok E, Beghin L, Gachon P, Daubrosse C, Fontan JE, Cuisset JM, Gottrand F, Hankard R. Estimating body composition in children with Duchenne muscular dystrophy: comparison of bioelectrical impedance analysis and skinfold-thickness measurement. Am J Clin Nutr. 2006 Jan;83(1):65-9. doi: 10.1093/ajcn/83.1.65.

    PubMed 16400051

  • Mok E, Letellier G, Cuisset JM, Denjean A, Gottrand F, Alberti C, Hankard R. Lack of functional benefit with glutamine versus placebo in Duchenne muscular dystrophy: a randomized crossover trial. PLoS One. 2009;4(5):e5448. doi: 10.1371/journal.pone.0005448. Epub 2009 May 6.

    PubMed 19421321

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing L-Glutamine in people with Muscular Dystrophy, Duchenne, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

walking speed at 0,2,4,5,7,9 months (time frame: at 0,2,4,5,7,9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00296621, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2007; AzTrials last refreshed its copy on 7 Nov 2026.

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