Mitochondrial Functions and Oxidative Stress in ALS Patients

NCT ID: NCT00331812

Last Updated: 2011-01-19

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

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-02-29

Brief Summary

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In Amyotrophic Lateral Sclerosis (ALS), malnutrition is frequent (16 to 50 % of the patients) and is an independent prognostic factor. One of the implicated factors is the increase of resting energy expenditure (REE) which can be found in about 50 % of ALS patients. The origin of this hypermetabolism is currently unknown but could be located in the mitochondria. In fact, some studies have found mitochondrial abnormalities and the existence of an oxidative stress. Thus, the aim of this study is to characterize the mitochondrial abnormalities and the oxidant/antioxidant status of ALS patients and to determine their relationship with the metabolic status, hypermetabolism or normometabolism. Three groups of patients will be studied : 20 hypermetabolic ALS patients, 20 normometabolic ALS patients and 20 healthy volunteers paired for age and sex.

Detailed Description

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In Amyotrophic Lateral Sclerosis (ALS), malnutrition is frequent (16 to 50 % of the patients) and is an independent prognostic factor. One of the implicated factors is the increase of resting energy expenditure (REE) which can be found in about 50 % of ALS patients. The origin of this hypermetabolism is currently unknown but could be located in the mitochondria. In fact, some studies have found mitochondrial abnormalities and the existence of an oxidative stress. Thus, the aim of this study is to characterize the mitochondrial abnormalities and the oxidant/antioxidant status of ALS patients and to determine their relationship with the metabolic status, hypermetabolism or normometabolism. Three groups of patients will be studied : 20 hypermetabolic ALS patients, 20 normometabolic ALS patients and 20 healthy volunteers paired for age and sex.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Mitochondrial functions and oxidative stress

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* male or female
* age \> 30 years
* definite or probable ALS according to the El Escorial criteria, bulbar or spinal form, ALS diagnosis \< 1 year and treatment by riluzole.

Exclusion Criteria

* family history of ALS,
* oral, enteral or parenteral nutritional supply,
* vitamin or trace element supplementation
* confusing illness (cancer, diabetes, chronic infectious or inflammatory disease,thyroid disorders, recent surgery...),
* current tobacco use,
* alcoholism
* treatment by corticosteroids,
* diuretics,
* anorectics
* NSAIDs
* cytotoxics
* anticoagulants...
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role collaborator

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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CHU Clermont-Ferrand

Principal Investigators

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Corinne Bouteloup, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corinne Bouteloup, Dr

Role: CONTACT

(+33) 04 73 75 05 04

References

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Desport JC, Preux PM, Magy L, Boirie Y, Vallat JM, Beaufrere B, Couratier P. Factors correlated with hypermetabolism in patients with amyotrophic lateral sclerosis. Am J Clin Nutr. 2001 Sep;74(3):328-34. doi: 10.1093/ajcn/74.3.328.

Reference Type BACKGROUND
PMID: 11522556 (View on PubMed)

Ferrante RJ, Browne SE, Shinobu LA, Bowling AC, Baik MJ, MacGarvey U, Kowall NW, Brown RH Jr, Beal MF. Evidence of increased oxidative damage in both sporadic and familial amyotrophic lateral sclerosis. J Neurochem. 1997 Nov;69(5):2064-74. doi: 10.1046/j.1471-4159.1997.69052064.x.

Reference Type BACKGROUND
PMID: 9349552 (View on PubMed)

Menzies FM, Ince PG, Shaw PJ. Mitochondrial involvement in amyotrophic lateral sclerosis. Neurochem Int. 2002 May;40(6):543-51. doi: 10.1016/s0197-0186(01)00125-5.

Reference Type BACKGROUND
PMID: 11850111 (View on PubMed)

Other Identifiers

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CHU63-0007

Identifier Type: -

Identifier Source: org_study_id

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