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Mitochondrial Functions and Oxidative Stress in ALS Patients

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Procedure: Mitochondrial functions and oxidative stress

Study type

Observational

Funder types

Other

Identifiers

NCT00331812
CHU63-0007

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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...

Trial contacts and locations

1

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Central trial contact

Corinne Bouteloup, Dr

Data sourced from clinicaltrials.gov

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