Mitochondrial Functions and Oxidative Stress in ALS Patients

Mitochondrial Functions and Oxidative Stress in ALS Patients
This study is currently recruiting participants.
Verified January 2011 by University Hospital, Clermont-Ferrand

First Received on May 23, 2006.  
Last Updated on January 18, 2011  
History of Changes
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: Time Perspective: Prospective
Official Title: Study of Mitochondrial Functions and Oxidative Stress in ALS Patients.

Resource links provided by NLM:

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
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

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
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:

Responsible Party: Dr Corinne BOUTELOUP, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00331812    
History of Changes
Other Study ID Numbers: CHU63-0007
Study First Received: May 23, 2006
Last Updated: January 18, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Hypermetabolism
Mitochondrial abnormalities
Oxidant/antioxidant status

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on August 21, 2012

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