Amyotrophic Lateral SclerosisMETABOCALSNCT03984708
New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.
A study testing Samples, Indirect calorimetry and Electrical bioimpedance in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Samples, Indirect calorimetry and Electrical bioimpedance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Jan 2020to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Age ≥ 18 years and ≥ 75 years
- No neuronal disease
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Who cannot join
- 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
Show all 18Show fewer
- Dermatological diseases of the fibroblast
- Skin cancer
- Protection measure for guardianship or curatorship
- Control group selection 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Neurology Department, University Hospital, Limoges
Limoges, 87042
Neurology Department, University Hospitla, Tours
Tours, 37044
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 metabolomic and lipidomic approaches, as well as the quantification transcriptomic approach."
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Samples, Indirect calorimetry, Electrical bioimpedance
- Keywords
- Amyotrophic Lateral Sclerosis, Metabolomics, Transcriptomics, Biomarkers, Fibroblast
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
Blood sample, skin biopsy
Indirect calorimetryOther
Measurement of energy expenditure by indirect calorimetry
Electrical bioimpedanceOther
Measurement of electrical bioimpedance
| Study group | Role | What they receive |
|---|---|---|
| Case group | Other | The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis Receives: Other: Samples; Other: Indirect calorimetry; Other: Electrical bioimpedance |
| Control group | Other | The intervention, specific to the study, is to take samples at baseline on patients without neurological disease Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
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
Measured: Baseline
Secondary outcomes (1)
Expression levels of targeted molecules using transcriptomics
Choice of molecules based on results obtained by metabolomics approaches
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start27 Jan 2020
- Primary completion10 Jan 2023
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène BLASCO, MD-PhD, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984708
- Sponsor's protocol ID
- DR180135
- Other IDs
- 2019-A00649-48
- Acronym
- METABOCALS
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2019
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.
- ClinicalTrials.gov ID
- NCT03984708
- Acronym / sponsor ID
- METABOCALS / DR180135
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Metabolomics, Transcriptomics, Biomarkers, Fibroblast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Other | Other: Samples, Other: Indirect calorimetry, Other: Electrical bioimpedanceThe intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis |
| Control group | Other | Other: SamplesThe intervention, specific to the study, is to take samples at baseline on patients without neurological disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Contraindication to local anesthesia
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplesBlood sample, skin biopsy | Other | Case group, Control group |
| Indirect calorimetryMeasurement of energy expenditure by indirect calorimetry | Other | Case group |
| Electrical bioimpedanceMeasurement of electrical bioimpedance | Other | Case group |
Primary outcome
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
1 secondary outcome
Expression levels of targeted molecules using transcriptomics
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hélène BLASCO, MD-PhD study director
University Hospital, Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samples, Indirect calorimetry and Electrical bioimpedance in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic signature of fibroblast : concentrations of molecules detected by mass spectrometry (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.