Study Purpose:
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects central and peripheral motor neurons. None of the clinical trials conducted have been clearly successful and the disease remains incurable, putting patients' vital prognosis at risk in the medium term. An alteration of the basal metabolism leading to hypermetabolism has been described in several articles in the literature. The causes of this hypermetabolism and the precise exploration of the metabolic pathways involved are still poorly understood. The fibroblasts of ALS patients may be the site of some metabolic disturbances in this disease with a hypothetical specific basal metabolic profile. These cells are adapted to different metabolic explorations such as omnic approaches. Superficial skin biopsy followed by fibroblast culture can provide a considerable biobank. This cellular richness will allow us, in ALS patients and their controls, to perform metabolomic and lipidomic approaches, as well as the quantification transcriptomic approach."Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Samples, Indirect calorimetry, Electrical bioimpedance
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Hélène BLASCO, MD-PhD, University Hospital, Tours
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Hélène BLASCO, MD-PhD / email hidden; JavaScript is required / 02.34.37.89.11
Full Study Summary:
Study Sponsor:
University Hospital, Tours
Estimated Enrollment:
90
Estimated Study Start Date:
01 / 27 / 2020
Estimated Study Completion Date:
01 / 01 / 2024
Posting Last Modified Date:
09 / 30 / 2021
Date Study Added to neals.org:
06 / 13 / 2019
Minimum Age:
18 Years
Maximum Age:
75 Years
Case group selection criteria:Inclusion Criteria:
- Age ≥ 18 years and ≥ 75 years
- ALS according to the El Escorial criteria
- Diagnosis of ALS < 6 months
- Symptoms onset < 2 years
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Exclusion Criteria:
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Contraindication to local anesthesia
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Dermatological diseases of the fibroblast
- Skin cancer
- Protection measure for guardianship or curatorship
Control group selection criteria:
Inclusion Criteria:
- Age ≥ 18 years and ≥ 75 years
- No neuronal disease
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Exclusion Criteria:
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Dermatological diseases of the fibroblast
- Skin cancer
- Protection measure for guardianship or curatorship
Neurology Department, University Hospital, Limoges | Recruiting
Philippe COURATIER, MD-PhD
Principal Investigator : Philippe COURATIER, MD-PhD
Limoges 87042
France
Neurology Department, University Hospitla, Tours | Recruiting
Philippe CORCIA, MD-PhD
Principal Investigator : Philippe CORCIA, MD-PhD
Tours 37044
France