Dissecting the Molecular and Cellular Pathophysiology of Sarcopenic Obesity in the Elderly

NCT ID: NCT06320158

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2025-12-31

Brief 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). 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

clinical evaluation of sarcopenic obesity

Intervention Type: OTHER

completion of scales and questionnaires, venous blood sampling, muscle ultrasound scan

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

clinical evaluation of sarcopenic obesity

Intervention Type: OTHER

completion of scales and questionnaires, venous blood sampling, muscle ultrasound scan

Interventions

clinical evaluation of sarcopenic obesity

completion of scales and questionnaires, venous blood sampling, muscle ultrasound scan

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

All partecipants

• unavailability to participate in the study
• inflammatory or neurological myopathies
• acute heart failure
• active cancer

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Rovere Querini Patrizia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Patrizia Rovere Querini, PhD, MD

Role: CONTACT

rovere.patrizia@hsr.it

+390226436095

Rebecca De Lorenzo, MD

Role: CONTACT

delorenzo.rebecca@hsr.it

+390226433065

Facility Contacts

Patrizia Rovere Querini, MD, PhD

Role: primary

rovere.patrizia@hsr.it

+390226433065

Rebecca De Lorenzo, MD

Role: backup

delorenzo.rebecca@hsr.it

+390226433065

Other Identifiers

PNRR-MAD-2022-12376672

Identifier Type: -

Identifier Source: org_study_id