Mitochondrial Functions and Oxidative Stress in ALS Patients

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Study of Mitochondrial Functions and Oxidative Stress in ALS Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00331812
• Other study ID #: CHU63-0007
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2006
• Last updated: January 18, 2011
• Start date: February 2006
• Est. completion date: February 2008

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Corinne Bouteloup, Dr
• Phone: (+33) 04 73 75 05 04
• Email: cbouteloup[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

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...

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis

Intervention

Procedure:
• Mitochondrial functions and oxidative stress

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Auvergne

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Institut National de la Recherche Agronomique, University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relationship between these abnormalities and the metabolic status (hypermetabolism or normometabolism).