Sarcopenic Obesity as a Risk of Premature Aging
- Conditions
- ObesitySarcopenic ObesityAging
- Interventions
- Other: No intervention, observational study
- Registration Number
- NCT05443711
- Lead Sponsor
- Hospital de Leon
- Brief Summary
Recently, numerous signaling proteins derived from adipose tissue and/or skeletal muscle have been described and are involved in the pathogenesis of obesity and the pathophysiology of aging. Current evidence suggests a role for the FGF-Klotho system, circulating cell-free DNA (cfDNA), miR-499, and exosomes not only in the pathophysiology of obesity, but also in the association with sarcopenic obesity (OS) and in a accelerated aging.
The investigator´s hypothesis is that obesity, especially OS, might be the cause of advanced aging, reflected in lower levels of the FGF-Klotho system, higher concentrations of cfDNA and a change in the profiles of miRNAs and exosomes, which could have an impact on risk. cardiovascular and metabolic.
For this, a descriptive cross-sectional study is proposed in 50 patients with obesity, who will be classified as OS or not, and 25 healthy controls, between 50-60 years old. The determinations are made by the IBIOMED of the University of León.
To study the evolution of aging markers over a year of follow-up, a second part of the study will analyze the possible differences according to the treatments assigned to each patient in the context of real life (lifestyle changes, drugs, bariatric surgery).
- Detailed Description
Descriptive cross-sectional study in patients with obesity attended in the High-Risk Obesity consultation of the University Assistance Complex of León, with a control group of healthy people of the same age group without obesity or cardiovascular risk factors that will be selected among volunteers from the CAULE and University of Leon staff.
The second part of the study will be a one-year prospective longitudinal follow-up study of the patients included in the first part of the study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- People, men and postmenopausal women, aged between 50 and 60 years. Diagnosis of central obesity with body mass index greater than or equal to 30 kg/m2 and waist circumference equal to or greater than 102 cm in men and 88 cm in women.
Control group, of healthy individuals with BMI less than 30 kg/m2 and waist circumference <102 cm in men and <88 cm in women, of the same age group and matched according to gender.
Able of giving informed consent.
- Premenopausal women. Kidney disease with glomerular filtration rate less than 60. Liver disease with plasma GOT/GPT/GGT levels greater than x 2 the upper limit of normal.
Active cancer disease. Heart or respiratory failure requiring pharmacological treatment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description obesity No intervention, observational study Patients with obesity attended in the High-Risk Obesity clinic of the Complejo ASistencial Universitario de León, 50-60 years-old control No intervention, observational study control group of healthy people of the same age group without obesity or cardiovascular risk factors that will be selected among volunteers from the CAULE staff. and University of Leon
- Primary Outcome Measures
Name Time Method S-Klotho levels 2022-2023 Exosomes 2022-2023 Blood samples
miR-499 2022-2023 Blood samples
cfDNA 2022-2023 Blood samples
- Secondary Outcome Measures
Name Time Method Muscle function 2 2022-2023 Strenght platform
Muscle function 2022-2023 Hand grip strength
Fat mass 2022-2023 DXA
Muscle mass 2022-2023 DXA
Trial Locations
- Locations (1)
Complejo Asistencial Universitario de León
🇪🇸León, Spain