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NCT06320158Recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1108 (estimated)
First submitted
13 Mar 2024
Start date
22 May 2023
Primary completion date
30 Nov 2025
Lead sponsor
IRCCS San Raffaele
Diseases
Obesity
NCT number
NCT06320158

What you commit to

  • Study type: Observational
  • Planned participants: 1108
  • From 22 May 2023 to the primary completion date, 30 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • acute heart failure
  • active cancer

Other

  • All partecipants
  • unavailability to participate in the study
  • inflammatory or neurological myopathies

Who the study is looking for

  • 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

Age in the registry: 65 years to 99 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.