Sarcopenic Obesity as a Risk of Premature Aging (SARCOBEAGING)

SARCOBEAGING: Sarcopenic Obesity as a Risk of Premature Aging

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Aging; Sarcopenic Obesity
• Intervention / Treatment: Other: No intervention, observational study

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.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

• Study Contact: Name: Octavio Rivero Lezcano, PhD; Phone Number: 43060 +34987237400; Email: orivero@saludcastillayleon.es

Study Locations

• Spain
  • León, Spain, 24008
    • Complejo Asistencial Universitario de León

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obesity; Patients with obesity attended in the High-Risk Obesity clinic of the Complejo ASistencial Universitario de León, 50-60 years-old	Other: No intervention, observational study; No intervention, observational study
control; 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	Other: No intervention, observational study; No intervention, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S-Klotho levels		2022-2023
miR-499	Blood samples	2022-2023
cfDNA	Blood samples	2022-2023
Exosomes	Blood samples	2022-2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass	DXA	2022-2023
Muscle mass	DXA	2022-2023
Muscle function	Hand grip strength	2022-2023
Muscle function 2	Strenght platform	2022-2023

Collaborators and Investigators

• Sponsor: Hospital de Leon
• Collaborators: Universidad de León
• Investigators: Study Director: Maria D Ballesteros Pomar, PhD, Complejo Asistencial Universitario de León

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Estimated): December 5, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: obesity; aging; miRNA; sarcopenia; klotho
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Aging, Premature
• Other Study ID Numbers: CAULE 21125; GRS 2326/A/21 (Other Grant/Funding Number: Gerencia Regional de Salud de Castilla y León)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No