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

Amyotrophic Lateral Sclerosis Clinical Trial

— METABOCALS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03984708
• Other study ID #: DR180135
• Secondary ID: 2019-A00649-48
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9
• Est. completion date: January 2024
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• Samples
Blood sample, skin biopsy
• Indirect calorimetry
Measurement of energy expenditure by indirect calorimetry
• Electrical bioimpedance
Measurement of electrical bioimpedance

Locations

Country	Name	City	State
France	Neurology Department, University Hospital, Limoges	Limoges
France	Neurology Department, University Hospitla, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic signature of fibroblast : concentrations of molecules detected by mass spectrometry	The metabolomic profile of fibroblast represents the combination of the different molecules detected/quantified by mass spectrometry	Baseline
Primary	Metabolic signature of blood : concentrations of molecules detected by mass spectrometry	The metabolomic profile of blood represents the combination of the different molecules detected/quantified by mass spectrometry	Baseline
Secondary	Expression levels of targeted molecules using transcriptomics	Choice of molecules based on results obtained by metabolomics approaches	Baseline