Mitochondrial Functions and Oxidative Stress in ALS Patients

• ClinicalTrials.gov Identifier: NCT00331812
• Recruitment Status: Unknown
• First Posted: May 31, 2006
• Last Update Posted: January 19, 2011
• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Limoges; Institut National de la Recherche Agronomique
• Information provided by: University Hospital, Clermont-Ferrand

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Amyotrophic Lateral Sclerosis	Procedure: Mitochondrial functions and oxidative stress

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 40 participants
• Time Perspective: Prospective
• Official Title: Study of Mitochondrial Functions and Oxidative Stress in ALS Patients.
• Study Start Date: February 2006
• Estimated Study Completion Date: February 2008

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

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

Contacts

Contact: Corinne Bouteloup, Dr; (+33) 04 73 75 05 04; cbouteloup@chu-clermontferrand.fr

Locations

France

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, Beaufrère 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: Dr Corinne BOUTELOUP, CHU Clermont-Ferrand
• ClinicalTrials.gov Identifier: NCT00331812
• Other Study ID Numbers: CHU63-0007
• First Posted: May 31, 2006
• Last Update Posted: January 19, 2011
• Last Verified: January 2011

Keywords provided by University Hospital, Clermont-Ferrand:

Hypermetabolism; Mitochondrial abnormalities; Oxidant/antioxidant status

Additional relevant MeSH terms:

Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases