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NCT Number: NCT03984708

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

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."

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurology Department, University Hospital, Limoges, Limoges, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samples

Other

Blood sample, skin biopsy

Indirect Calorimetry

Other

Measurement of energy expenditure by indirect calorimetry

Electrical bioimpedance

Other

Measurement of electrical bioimpedance

Primary outcomes

  1. Metabolic signature of fibroblast : concentrations of molecules detected by mass spectrometry

    Time frame: Baseline

    The metabolomic profile of fibroblast represents the combination of the different molecules detected/quantified by mass spectrometry

  2. Metabolic signature of blood : concentrations of molecules detected by mass spectrometry

    Time frame: Baseline

    The metabolomic profile of blood represents the combination of the different molecules detected/quantified by mass spectrometry

Secondary outcomes

  1. Expression levels of targeted molecules using transcriptomics

    Time frame: Baseline

    Choice of molecules based on results obtained by metabolomics approaches

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: METABOCALS

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 13, 2019
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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