Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03984708
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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."

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Samples Other: Indirect calorimetry Other: Electrical bioimpedance Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Case group
The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis
 Other: Samples
Blood sample, skin biopsy

Other: Indirect calorimetry
Measurement of energy expenditure by indirect calorimetry

Other: Electrical bioimpedance
Measurement of electrical bioimpedance
Control group
The intervention, specific to the study, is to take samples at baseline on patients without neurological disease
 Other: Samples
Blood sample, skin biopsy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  1. Expression levels of targeted molecules using transcriptomics [ Time Frame: Baseline ]
    Choice of molecules based on results obtained by metabolomics approaches


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984708


Contacts
Layout table for location contacts
Contact: Hélène BLASCO, MD-PhD 02.34.37.89.11 ext +33 helene.blasco@univ-tours.fr

Locations
Layout table for location information
France
Neurology Department, University Hospital, Limoges Recruiting
Limoges, France, 87042
Contact: Philippe COURATIER, MD-PhD         
Principal Investigator: Philippe COURATIER, MD-PhD         
Neurology Department, University Hospitla, Tours Recruiting
Tours, France, 37044
Contact: Philippe CORCIA, MD-PhD         
Principal Investigator: Philippe CORCIA, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Layout table for investigator information
Study Director: Hélène BLASCO, MD-PhD University Hospital, Tours
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03984708    
Other Study ID Numbers: DR180135
2019-A00649-48 ( Other Identifier: IdRCB )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Amyotrophic Lateral Sclerosis
Metabolomics
Transcriptomics
Biomarkers
Fibroblast
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases