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Clinical Trials/NCT03984708
NCT03984708
Completed
Not Applicable

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

University Hospital, Tours2 sites in 1 country9 target enrollmentJanuary 27, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amyotrophic Lateral Sclerosis
Sponsor
University Hospital, Tours
Enrollment
9
Locations
2
Primary Endpoint
Metabolic signature of blood : concentrations of molecules detected by mass spectrometry
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2020
End Date
March 5, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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:

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Expression levels of targeted molecules using transcriptomics(Baseline)

Study Sites (2)

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