Mitochondrial Functions and Oxidative Stress in ALS Patients - Full Text View

Sponsor:	University Hospital, Clermont-Ferrand
Collaborators:	University Hospital, Limoges Institut National de la Recherche Agronomique
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00331812

Purpose

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.

Condition	Intervention
Amyotrophic Lateral Sclerosis	Procedure: Mitochondrial functions and oxidative stress

Study Type:	Observational
Study Design:	Prospective
Official Title:	Study of Mitochondrial Functions and Oxidative Stress in ALS Patients.

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Antioxidants

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

relationship between these abnormalities and the metabolic status (hypermetabolism or normometabolism).

Estimated Enrollment:	40
Study Start Date:	February 2006
Estimated Study Completion Date:	February 2008

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Study Population

Three groups of patients will be studied : 20 hypermetabolic ALS patients, 20 normometabolic ALS patients and 20 healthy volunteers paired for age and sex.

Criteria

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...

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331812

Contacts

Contact: Corinne Bouteloup, Dr

(+33) 04 73 75 05 04

cbouteloup@chu-clermontferrand.fr

Locations

France, Auvergne
Clermont-Ferrand University Hospital	Recruiting
Clermont-Ferrand, Auvergne, France, 63000

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

University Hospital, Limoges

Institut National de la Recherche Agronomique

Investigators

Principal Investigator:

Corinne Bouteloup, Dr

University Hospital, Clermont-Ferrand

More Information

Publications:

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.

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.

Menzies FM, Ince PG, Shaw PJ. Mitochondrial involvement in amyotrophic lateral sclerosis. Neurochem Int. 2002 May;40(6):543-51. Review.

Responsible Party:	CHU Clermont-Ferrand ( Dr Corinne BOUTELOUP )
Study ID Numbers:	CHU63-0007
Study First Received:	May 23, 2006
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00331812 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Hypermetabolism
Mitochondrial abnormalities
Oxidant/antioxidant status

Additional relevant MeSH terms:

Pathologic Processes
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Nervous System Diseases

Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Motor Neuron Disease

ClinicalTrials.gov processed this record on November 30, 2009