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Mitochondrial Functions and Oxidative Stress in ALS Patients

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

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.

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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





Primary Outcome Measures :
  1. relationship between these abnormalities and the metabolic status (hypermetabolism or normometabolism).


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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...

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331812


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

Locations
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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
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Principal Investigator: Corinne Bouteloup, Dr University Hospital, Clermont-Ferrand

Publications:
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Responsible Party: Dr Corinne BOUTELOUP, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00331812     History of Changes
Other Study ID Numbers: CHU63-0007
First Posted: May 31, 2006    Key Record Dates
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:
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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