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New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.

NCT ID: NCT03984708

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-27

Study Completion Date

2024-03-05

Brief Summary

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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."

Detailed Description

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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 experiments for the quantification of metabolites by metabolic and lipidomic approaches, as well as the quantification of mRNAs and the rate of gene transcription by a transcriptomic approach.

Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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Amyotrophic Lateral Sclerosis Metabolomics Transcriptomics Biomarkers Fibroblast

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Case group

The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis

Group Type OTHER

Samples

Intervention Type OTHER

Blood sample, skin biopsy

Indirect calorimetry

Intervention Type OTHER

Measurement of energy expenditure by indirect calorimetry

Electrical bioimpedance

Intervention Type OTHER

Measurement of electrical bioimpedance

Control group

The intervention, specific to the study, is to take samples at baseline on patients without neurological disease

Group Type OTHER

Samples

Intervention Type OTHER

Blood sample, skin biopsy

Interventions

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Samples

Blood sample, skin biopsy

Intervention Type OTHER

Indirect calorimetry

Measurement of energy expenditure by indirect calorimetry

Intervention Type OTHER

Electrical bioimpedance

Measurement of electrical bioimpedance

Intervention Type OTHER

Eligibility Criteria

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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


* 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
* 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:


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hélène BLASCO, MD-PhD

Role: STUDY_DIRECTOR

University Hospital, Tours

Locations

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Neurology Department, University Hospital, Limoges

Limoges, , France

Site Status

Neurology Department, University Hospitla, Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2019-A00649-48

Identifier Type: OTHER

Identifier Source: secondary_id

DR180135

Identifier Type: -

Identifier Source: org_study_id