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

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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

Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE June 13, 2019
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE January 27, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
Expression levels of targeted molecules using transcriptomics [ Time Frame: Baseline ]
Choice of molecules based on results obtained by metabolomics approaches
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.
Official Title  ICMJE New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Other: Samples
    Blood sample, skin biopsy
  • Other: Indirect calorimetry
    Measurement of energy expenditure by indirect calorimetry
  • Other: Electrical bioimpedance
    Measurement of electrical bioimpedance
Study Arms  ICMJE
  • Case group
    The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis
    Interventions:
    • Other: Samples
    • Other: Indirect calorimetry
    • Other: Electrical bioimpedance
  • Control group
    The intervention, specific to the study, is to take samples at baseline on patients without neurological disease
    Intervention: Other: Samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 12, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Hélène BLASCO, MD-PhD 02.34.37.89.11 ext +33 helene.blasco@univ-tours.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984708
Other Study ID Numbers  ICMJE DR180135
2019-A00649-48 ( Other Identifier: IdRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Tours
Study Sponsor  ICMJE University Hospital, Tours
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hélène BLASCO, MD-PhD University Hospital, Tours
PRS Account University Hospital, Tours
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP