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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
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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