Sarcopenic Obesity as a Risk of Premature Aging

Obesity Clinical Trial

— SARCOBEAGING  

Official title:

SARCOBEAGING: Sarcopenic Obesity as a Risk of Premature Aging

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05443711
• Other study ID #: CAULE 21125
• Secondary ID: GRS 2326/A/21
• Status: Active, not recruiting
• Start date: January 19, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Hospital de Leon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: December 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Aging, Premature
• Obesity
• Sarcopenic Obesity

Intervention

Other:
• No intervention, observational study
No intervention, observational study

Locations

Country	Name	City	State
Spain	Complejo Asistencial Universitario de León	León

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Leon	Universidad de León

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S-Klotho levels		2022-2023
Primary	miR-499	Blood samples	2022-2023
Primary	cfDNA	Blood samples	2022-2023
Primary	Exosomes	Blood samples	2022-2023
Secondary	Fat mass	DXA	2022-2023
Secondary	Muscle mass	DXA	2022-2023
Secondary	Muscle function	Hand grip strength	2022-2023
Secondary	Muscle function 2	Strenght platform	2022-2023