AgingFRAMITONCT06433427
Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction
An observational study of Aging and Frailty, run by University Hospital of Ferrara.
Trial summary
The goal of this observational study is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Frailty, Mitochondrial Dysfunction
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2024to 22 Feb 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The study will enroll individuals aged 65 years or older. The enrollment will take place among patients accessing geriatric outpatient clinics or being discharged from geriatric wards in clinically stable conditions.
Who may be able to join
- Age ≥ 65 years
- Stable clinical conditions
- Willingness to participate in the study (provision of informed consent)
- Proficiency in the Italian language
Who cannot join
- Acute or unstable clinical conditions
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this observational study is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. The main questions it aims to answer are:
- What is the role of oxidative stress-related mitochondrial dysfunction in frailty, taking into account the interaction with multimorbidity.
- What could be the specific biomarkers associated with mitochondrial dysfunction in the assessment of frailty.
Read more
In order to reach the study goals, we will enroll three categories of older adults:
- Non-Frail without Multimorbidity (NFWoM);
- Frail with Multimorbidity (FWM);
- Frail without Multimorbidity (FWoM).
Each individual will undergo an assessment of frailty phenotype and multimorbidity, and the collection of blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). The identification of frailty biomarkers in each group of participants will be performed by combining untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and their subpopulations. Multivariate statistical and machine learning techniques will characterize the three clinical phenotype groups based on molecular data.
Read the detailed description
Study type: observational prospective study. Primary aim: is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity.
Primary endpoint: mitochondrial dysfunction in frailty. Secondary aims: to combine untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and PBMC subpopulations (B lymphocytes, T lymphocytes and monocytes).
The research activities are organized in the following tasks:
- Task 1, Patient Enrollment: We will enroll individuals aged 65 years or older from geriatric outpatient clinics or geriatric wards. For each individual, we will perform an assessment of frailty and multimorbidity, and collect blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). Three categories of individuals will be enrolled: 25 non-frail individuals without multimorbidity (NFWoM), 25 frail individuals with multimorbidity (FWM), and 25 frail individuals without multimorbidity (FWoM).
- Task 2, Separation of PBMC Subpopulations: T lymphocytes, B lymphocytes, and monocytes will be separated from frozen PBMCs using the Cell Sorting Facility for Fluorescence-Activated Cell Sorting (FACS) separation and the MoFlo Astrios cell sorter. The analyses on CD45+/CD3+/CD19-/CD14- T lymphocytes, CD45+/CD3-/CD19+/CD14- B lymphocytes, CD45+/CD3-/CD19-/CD14+ monocytes.
- Task 3, Mitochondrial Dysfunction Analysis on PBMCs and PBMC Subpopulations: For each individual, mitochondrial dysfunction will be evaluated by analyzing mtDNA damage (by Real-Time PCR), mitochondrial mass alteration (by Mitotracker staining), and intracellular and mitochondrial Reactive Oxygen Species (by DCF and MitoSOX staining). Moreover, we will evaluate alteration of glycolytic and mitochondrial metabolism using Agilent Seahorse Extracellular Flux Analyzer XFe96.
- Task 4, Untargeted Metabolomics on PBMCs and PBMC Subpopulations: To assess metabolic signature of PBMCs and subpopulations and highlight metabolic dysregulations linked to frailty, we will perform untargeted LC-MS-based metabolomics on PBMCs, T lymphocytes, B lymphocytes, and monocytes. The analysis on the polar metabolome will allow us to understand better the metabolic alterations associated with mitochondrial dysregulation.
- Task 5, Characterization of Biomarkers and Molecular Mechanism of Frailty: The potential biomarkers of frailty and the molecular mechanisms involved in mitochondrial dysfunction will be studied using statistical and machine learning techniques on molecular, metabolic and clinical data. This step will help characterize clinical phenotypes based on molecular measurements.
- Conditions
- Aging, Frailty, Mitochondrial Dysfunction, Chronic Disease
- Keywords
- Metabolic dysregulation
- Medical subject headings
- Frailty, Mitochondrial Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-Frail without Multimorbidity (NFWoM) | Individuals aged 65 years or older without frailty and without multimorbidity. This group will serve as a reference for participants who are not frail and do not have multiple chronic conditions. | |
| Frail with Multimorbidity (FWM) | Frail individuals aged 65 years or older who have multimorbidity. This group will include participants who exhibit frailty and have two or more chronic diseases. | |
| Frail without Multimorbidity (FWoM) | Frail individuals aged 65 years or older without multimorbidity. This group will help assess frailty in the absence of multiple chronic conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the mtDNA copy number between frail individuals with vs without multimorbidity
mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels.
The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases.
Measured: Baseline
Difference in the mtDNA copy number between non-frail vs frail individuals without multimorbidity
mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels.
The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases.
Measured: Baseline
Secondary outcomes (6)
Variation in the mean intensity of mitochondrial fluorescence between non-frail vs frail individuals without multimorbidity
500,000 PBMCs obtained from the study participants will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 100 nM Mitotracker Deep Red (Thermo Fisher Scientific) for 30 minutes at 30°C. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry with MoFLO Astrios cell sorter. Mitochondrial mass, evaluated as the median fluorescence intensity (MFI) of Mitotracker Deep Red, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
Measured: Baseline
Variation in the mean intensity of mitochondrial fluorescence between frail individuals with vs without multimorbidity
500,000 PBMCs obtained from the study participants will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 100 nM Mitotracker Deep Red (Thermo Fisher Scientific) for 30 minutes at 30°C. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry with MoFLO Astrios cell sorter. Mitochondrial mass, evaluated as the median fluorescence intensity (MFI) of Mitotracker Deep Red, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
Measured: Baseline
Difference of intracellular Reactive Oxygen Species (ROS) between non-frail vs frail individuals without multimorbidity
The fluorescent cell-permeable indicator 2',7'-dichlorofluorescin diacetate (DCFH-DA) will be used for detecting intracellular ROS. DCFH-DA is deacetylated by cellular esterases to a non-fluorescent compound, which is later oxidised by ROS into fluorescent 2',7'-dichlorofluorescein (DCF). The intensity of the generated fluorescent signal correlates with the intracellular level of ROS. 500,000 PBMCs obtained from 25 NFWoM, 25 FWM and 25 FWoM subjects will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 10 μM 2',7'-dichlorofluorescin diacetate (DCFH-DA) at 37°C for 30 minutes. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry. Intracellular ROS, evaluated as the median fluorescence intensity (MFI) of DCF, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
Measured: Baseline
Difference of intracellular Reactive Oxygen Species (ROS) between frail individuals with vs without multimorbidity
The fluorescent cell-permeable indicator 2',7'-dichlorofluorescin diacetate (DCFH-DA) will be used for detecting intracellular ROS. DCFH-DA is deacetylated by cellular esterases to a non-fluorescent compound, which is later oxidised by ROS into fluorescent 2',7'-dichlorofluorescein (DCF). The intensity of the generated fluorescent signal correlates with the intracellular level of ROS. 500,000 PBMCs obtained from 25 NFWoM, 25 FWM and 25 FWoM subjects will be stained with CD45, CD3, CD19 and CD14 antibodies and incubated with 10 μM 2',7'-dichlorofluorescin diacetate (DCFH-DA) at 37°C for 30 minutes. Cells will be also labelled with Live/Dead dye and analyzed by flow cytometry. Intracellular ROS, evaluated as the median fluorescence intensity (MFI) of DCF, will be assessed in total PBMCs, T and B lymphocytes and monocytes. 40,000 events in each population gate will be acquired and offline analysis will be performed with Kaluza software.
Measured: Baseline
Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between non-frail vs frail individuals without multimorbidity
Untargeted LC-MS-based metabolomics will be performed on PBMCs and on T and B lymphocytes and monocytes, obtained as described in Task 2. Cell samples will be quenched using cold methanol. After protein precipitation, metabolites will be extracted and analysed by liquid chromatography mass spectrometry (LC-MS). Hydrophilic interaction chromatography (HILIC) will be used to resolve the polar metabolome before MS detection using an Agilent 6546 lc/q-tof instrument (Agilent).The whole protein content will be quantified with NanoDrop™ (Thermofisher) and used to normalize the metabolic profile of each sample.
Measured: Baseline
Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between frail individuals with vs without multimorbidity
Untargeted LC-MS-based metabolomics will be performed on PBMCs and on T and B lymphocytes and monocytes, obtained as described in Task 2. Cell samples will be quenched using cold methanol. After protein precipitation, metabolites will be extracted and analysed by liquid chromatography mass spectrometry (LC-MS). Hydrophilic interaction chromatography (HILIC) will be used to resolve the polar metabolome before MS detection using an Agilent 6546 lc/q-tof instrument (Agilent).The whole protein content will be quantified with NanoDrop™ (Thermofisher) and used to normalize the metabolic profile of each sample.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start29 May 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion22 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Sponsor
- Investigators
- Caterina Trevisan, PhD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433427
- Sponsor's protocol ID
- 653/2023/Oss/AOUFe
- Acronym
- FRAMITO
- Status last verified
- Jan 2024
- First submitted
- 14 Mar 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Locatelli E, Torsello B, De Marco S, Lombardi M, Remelli F, Pampolini G, Ferrighi E, Bursi M, Bellotti A, Pasquale V, Ducci G, Navaei O, Candeloro R, Ferrara MC, Guo W, Cucini E, Bellelli G, Castellazzi M, Sacco E, Paglia G, Mazzola P, Bernasconi DP, Bianchi C, Trevisan C. Mitochondrial dysfunction as a biomarker of frailty: The FRAMITO study protocol. Arch Gerontol Geriatr. 2025 Jun;133:105803. doi: 10.1016/j.archger.2025.105803. Epub 2025 Feb 26.
PubMed 40043348
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Dysregulation as Biomarker of Frailty: Role of the Mitochondrial Dysfunction
- ClinicalTrials.gov ID
- NCT06433427
- Acronym / sponsor ID
- FRAMITO / 653/2023/Oss/AOUFe
- Conditions
- Aging, Frailty, Mitochondrial Dysfunction, Chronic Disease
- Keywords
- Metabolic dysregulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- 29 May 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 22 Feb 2026 (estimated)
- First posted
- 29 May 2024 (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.
The goal of this observational study is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity, and to identify possible frailty biomarkers correlated with mitochondrial dysfunction. The main questions it aims to answer are:
- What is the role of oxidative stress-related mitochondrial dysfunction in frailty, taking into account the interaction with multimorbidity.
- What could be the specific biomarkers associated with mitochondrial dysfunction in the assessment of frailty.
In order to reach the study goals, we will enroll three categories of older adults:
- Non-Frail without Multimorbidity (NFWoM);
- Frail with Multimorbidity (FWM);
- Frail without Multimorbidity (FWoM).
Each individual will undergo an assessment of frailty phenotype and multimorbidity, and the collection of blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). The identification of frailty biomarkers in each group of participants will be performed by combining untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and their subpopulations. Multivariate statistical and machine learning techniques will characterize the three clinical phenotype groups based on molecular data.
Detailed description
Study type: observational prospective study. Primary aim: is to evaluate the presence of mitochondrial dysfunction related to oxidative stress and its possible role in frailty, with and without multimorbidity.
Primary endpoint: mitochondrial dysfunction in frailty. Secondary aims: to combine untargeted metabolomics-based approaches and functional studies on specific mitochondrial dysfunctions performed on PBMCs and PBMC subpopulations (B lymphocytes, T lymphocytes and monocytes).
The research activities are organized in the following tasks:
- Task 1, Patient Enrollment: We will enroll individuals aged 65 years or older from geriatric outpatient clinics or geriatric wards. For each individual, we will perform an assessment of frailty and multimorbidity, and collect blood samples to isolate Peripheral Blood Mononuclear Cells (PBMCs). Three categories of individuals will be enrolled: 25 non-frail individuals without multimorbidity (NFWoM), 25 frail individuals with multimorbidity (FWM), and 25 frail individuals without multimorbidity (FWoM).
- Task 2, Separation of PBMC Subpopulations: T lymphocytes, B lymphocytes, and monocytes will be separated from frozen PBMCs using the Cell Sorting Facility for Fluorescence-Activated Cell Sorting (FACS) separation and the MoFlo Astrios cell sorter. The analyses on CD45+/CD3+/CD19-/CD14- T lymphocytes, CD45+/CD3-/CD19+/CD14- B lymphocytes, CD45+/CD3-/CD19-/CD14+ monocytes.
- Task 3, Mitochondrial Dysfunction Analysis on PBMCs and PBMC Subpopulations: For each individual, mitochondrial dysfunction will be evaluated by analyzing mtDNA damage (by Real-Time PCR), mitochondrial mass alteration (by Mitotracker staining), and intracellular and mitochondrial Reactive Oxygen Species (by DCF and MitoSOX staining). Moreover, we will evaluate alteration of glycolytic and mitochondrial metabolism using Agilent Seahorse Extracellular Flux Analyzer XFe96.
- Task 4, Untargeted Metabolomics on PBMCs and PBMC Subpopulations: To assess metabolic signature of PBMCs and subpopulations and highlight metabolic dysregulations linked to frailty, we will perform untargeted LC-MS-based metabolomics on PBMCs, T lymphocytes, B lymphocytes, and monocytes. The analysis on the polar metabolome will allow us to understand better the metabolic alterations associated with mitochondrial dysregulation.
- Task 5, Characterization of Biomarkers and Molecular Mechanism of Frailty: The potential biomarkers of frailty and the molecular mechanisms involved in mitochondrial dysfunction will be studied using statistical and machine learning techniques on molecular, metabolic and clinical data. This step will help characterize clinical phenotypes based on molecular measurements.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Frail without Multimorbidity (NFWoM) | – | –Individuals aged 65 years or older without frailty and without multimorbidity. This group will serve as a reference for participants who are not frail and do not have multiple chronic conditions. |
| Frail with Multimorbidity (FWM) | – | –Frail individuals aged 65 years or older who have multimorbidity. This group will include participants who exhibit frailty and have two or more chronic diseases. |
| Frail without Multimorbidity (FWoM) | – | –Frail individuals aged 65 years or older without multimorbidity. This group will help assess frailty in the absence of multiple chronic conditions. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The study will enroll individuals aged 65 years or older. The enrollment will take place among patients accessing geriatric outpatient clinics or being discharged from geriatric wards in clinically stable conditions.
Key inclusion criteria (4 listed)
- Age ≥ 65 years
- Stable clinical conditions
- Willingness to participate in the study (provision of informed consent)
- Proficiency in the Italian language
Key exclusion criteria (1 listed)
- Acute or unstable clinical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in the mtDNA copy number between frail individuals with vs without multimorbidity
Time frame: Baseline
mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels. The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases.
Difference in the mtDNA copy number between non-frail vs frail individuals without multimorbidity
Time frame: Baseline
mtDNA copies isolated from total PBMCs and from T and B lymphocytes and monocytes, obtained from the participants, with JetQuick™ Blood and Cell Culture DNA Midiprep Kit (Invitrogen), and 10 ng of DNA will be used for analysis on QuantumStudio 7 Real Time PCR (Applied Biosystems). mtDNA copy number will be calculated by normalising the mitochondrial ND1 gene (mtND1) levels to nuclear Beta-2 microglobulin (B2M) levels. The number mtDNA copies will be compared between individuals with frailty and multimorbidity vs individuals with frailty without multimorbidity. Frailty will be derived based on the presence of at least three criteria among: involuntary weight loss ≥ 4.5 kg, muscle weakness measured by handgrip, self-reported fatigue on ≥ 3 days per week, low physical activity (assessed with the IPAQ questionnaire), and reduced gait speed (measured by the 4-m walking test). Multimorbidity will be defined as the presence of at least two chronic diseases.
6 secondary outcomes
Variation in the mean intensity of mitochondrial fluorescence between non-frail vs frail individuals without multimorbidity
Time frame: Baseline
Variation in the mean intensity of mitochondrial fluorescence between frail individuals with vs without multimorbidity
Time frame: Baseline
Difference of intracellular Reactive Oxygen Species (ROS) between non-frail vs frail individuals without multimorbidity
Time frame: Baseline
Difference of intracellular Reactive Oxygen Species (ROS) between frail individuals with vs without multimorbidity
Time frame: Baseline
Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between non-frail vs frail individuals without multimorbidity
Time frame: Baseline
Qualitative difference in metabolomics profiles of PBMCs and PBMC subpopulations between frail individuals with vs without multimorbidity
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 40043348Locatelli E, Torsello B, De Marco S, Lombardi M, Remelli F, Pampolini G, Ferrighi E, Bursi M, Bellotti A, Pasquale V, Ducci G, Navaei O, Candeloro R, Ferrara MC, Guo W, Cucini E, Bellelli G, Castellazzi M, Sacco E, Paglia G, Mazzola P, Bernasconi DP, Bianchi C, Trevisan C. Mitochondrial dysfunction as a biomarker of frailty: The FRAMITO study protocol. Arch Gerontol Geriatr. 2025 Jun;133:105803. doi: 10.1016/j.archger.2025.105803. Epub 2025 Feb 26.
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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.
Caterina Trevisan, PhD principal investigator
Università degli Studi di Ferrara
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Frailty, run by University Hospital of Ferrara.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caterina Trevisan, PhD (00393896743650, caterina.trevisan@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the mtDNA copy number between frail individuals with vs without multimorbidity (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?
On the ClinicalTrials.gov record for NCT06433427, which also lists 1 linked publication.
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 29 May 2024.