Mitochondrial Functions and Oxidative Stress in ALS Patients

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT00331812
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-05-23
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Study Completion: 2008-02
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Auvergne, France