Sarcopenic ObesityNCT06320158
Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly
An observational study of Sarcopenic Obesity, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Sarcopenic Obesity
- What is being tested?
- clinical evaluation of sarcopenic obesity
- How many people
- 1,108 participants
- Where
- 1 siteItaly
- Study dates
- 22 May 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Older adult
Study population: patients who are candidates for hip surgery: 60 patients who are candidates for hip surgery. Specifically, we will select 15 obese and sarcopenic patients, 15 obese and non-sarcopenic patients, 15 non-obese and sarcopenic patients, and 15 non-obese and non-sarcopenic patients. healthy subjects:subjects from a previous cohort of healthy volunteers studied in 2016-2017. In particular, we will select overweight or obese subjects who did not have sarcopenia at the time of the 2016-2017 evaluation
Who may be able to join
- patients who are candidates for hip surgery
- patients who are candidates for hip surgery
- age ≥ 65 years
- patients able to give consent
- healthy subjects
- healthy subjects from the geriatric cohort studied in 2016-2017 who at that time were: were overweight (25 ≤ BMI < 30 kg/m2) or obese (BMI ≥ 30 kg/m2) but had not yet developed sarcopenia
Who cannot join
- All partecipants
- unavailability to participate in the study
- inflammatory or neurological myopathies
- acute heart failure
- active cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, 20132
Patrizia Rovere Querini, MD, PhD, +390226433065, rovere.patrizia@hsr.it
Rebecca De Lorenzo, MD, +390226433065, delorenzo.rebecca@hsr.it
About this study
Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population.
The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years.
- Conditions
- Sarcopenic Obesity
- Being tested
- clinical evaluation of sarcopenic obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical evaluation of sarcopenic obesityOther
completion of scales and questionnaires, venous blood sampling, muscle ultrasound scan
| Study group | Role | What they receive |
|---|---|---|
| patients who are candidates for hip surgery | cohort of patients who are candidates for hip surgery: completion of scales and questionnaires, venous blood sampling, muscle ultrasound scan Receives: Other: clinical evaluation of sarcopenic obesity | |
| healthy subjects | cohort of healthy subjects recruited in 2016-2017 completion of scales, questionnaires and performance of the Short Physical Performance Battery test, venous blood sampling, muscle ultrasound scan Receives: Other: clinical evaluation of sarcopenic obesity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying new molecular markers in elderly patients with sarcopenic obesity
Identifying new molecular markers in elderly patients with sarcopenic obesity
Measured: May 2023- October 2024
Secondary outcomes (1)
Assessing the ability of new markers (identified in the pre-clinical phase of this project) to predict individual disease trajectories
Assessing the ability of new markers (identified in the pre-clinical phase of this project) to predict individual disease trajectories
Measured: May 2023- October 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start22 May 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rovere Querini Patrizia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320158
- Sponsor's protocol ID
- PNRR-MAD-2022-12376672
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly
- ClinicalTrials.gov ID
- NCT06320158
- Acronym / sponsor ID
- PNRR-MAD-2022-12376672
- Conditions
- Sarcopenic Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,108 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Mar 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.
Ageing is characterised by a change in body composition with a parallel decrease in muscle mass and an increase and central redistribution of fat. When drastically exacerbated, these two processes culminate in a condition known as sarcopenic obesity (SO). SO is characterised by the coexistence of obesity and sarcopenia (i.e. reduced muscle mass and function) and is a growing public health problem in the elderly. The health risks of obesity and sarcopenia act synergistically, maximising the risk of disability of OS. The molecular mechanisms underlying OS are largely unknown. Increased fat mass induces chronic systemic inflammation and alters the profiles of adipokines and hormones, promoting the development of sarcopenia. On the other hand, the reduction in muscle tissue (SM) typical of sarcopenia is characterised by an alteration in the metabolic properties of skeletal muscle with an increase in insulin resistance and a reduction in energy expenditure that favours the accumulation and dysfunction of adipose tissue (AT). The cellular alterations that would seem to underlie OS are: altered autophagy, cellular senescence, epigenetic and mitochondrial alterations and maladaptive activation of intra- and intercellular inflammatory circuits (e.g. cytokines, extracellular vesicles, dysfunctional circulating leukocytes). However, the interconnections between these mechanisms are still unclear. The impact of OS can be dramatic on the health and quality of life of those affected. Therefore, the identification of early biomarkers that can recognise overweight and obese individuals at risk of developing SO is of paramount importance. This would shed light on the heterogeneity of an otherwise homogeneous clinical condition, opening new horizons towards the conscious design of more personalised therapeutic strategies, allowing a more rational use of the limited resources available for the growing elderly population.
The study design designed to achieve this aim is a cross-sectional observational study with an additional multicentre procedure lasting two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who are candidates for hip surgery | – | Other: clinical evaluation of sarcopenic obesitycohort of patients who are candidates for hip surgery: completion of scales and questionnaires, venous blood sampling, muscle ultrasound scan |
| healthy subjects | – | Other: clinical evaluation of sarcopenic obesitycohort of healthy subjects recruited in 2016-2017 completion of scales, questionnaires and performance of the Short Physical Performance Battery test, venous blood sampling, muscle ultrasound scan |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Age groups
- Older adult
- Study population
- patients who are candidates for hip surgery: 60 patients who are candidates for hip surgery. Specifically, we will select 15 obese and sarcopenic patients, 15 obese and non-sarcopenic patients, 15 non-obese and sarcopenic patients, and 15 non-obese and non-sarcopenic patients. healthy subjects:subjects from a previous cohort of healthy volunteers studied in 2016-2017. In particular, we will select overweight or obese subjects who did not have sarcopenia at the time of the 2016-2017 evaluation
Key inclusion criteria (6 listed)
- patients who are candidates for hip surgery
- patients who are candidates for hip surgery
- age ≥ 65 years
- patients able to give consent
- healthy subjects
Key exclusion criteria (5 listed)
- All partecipants
- unavailability to participate in the study
- inflammatory or neurological myopathies
- acute heart failure
- active cancer
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 |
|---|---|---|
| clinical evaluation of sarcopenic obesitycompletion of scales and questionnaires, venous blood sampling, muscle ultrasound scan | Other | healthy subjects, patients who are candidates for hip surgery |
Primary outcome
Identifying new molecular markers in elderly patients with sarcopenic obesity
Time frame: May 2023- October 2024
Identifying new molecular markers in elderly patients with sarcopenic obesity
1 secondary outcome
Assessing the ability of new markers (identified in the pre-clinical phase of this project) to predict individual disease trajectories
Time frame: May 2023- October 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity, run by IRCCS San Raffaele at 1 site in Italy.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Rovere Querini, PhD, MD (+390226436095, rovere.patrizia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying new molecular markers in elderly patients with sarcopenic obesity (time frame: May 2023- October 2024). 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 18 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.