Clinical trial NCT05443711: Sarcopenic Obesity as a Risk of Premature Aging
Official title: SARCOBEAGING: Sarcopenic Obesity as a Risk of Premature Aging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Sarcopenic Obesity
Aging
Keywords: obesity
sarcopenia
aging
klotho
miRNA
Lead sponsor: Hospital de Leon
Sponsor class: OTHER_GOV
Collaborators: name: Universidad de León
First posted: 2022-07-05
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: S-Klotho levels
timeFrame: 2022-2023
measure: miR-499
timeFrame: 2022-2023
measure: cfDNA
timeFrame: 2022-2023
measure: Exosomes
timeFrame: 2022-2023
Secondary outcomes:
measure: Fat mass
timeFrame: 2022-2023
measure: Muscle mass
timeFrame: 2022-2023
measure: Muscle function
timeFrame: 2022-2023
measure: Muscle function 2
timeFrame: 2022-2023
Other outcomes:
Locations:
city: León
country: Spain
facility: Complejo Asistencial Universitario de León
Study officials:
affiliation: Complejo Asistencial Universitario de León
name: Maria D Ballesteros Pomar, PhD
role: STUDY_DIRECTOR
References: