Sarcopenic Obesity as a Risk of Premature Aging

NCT05443711 | Active Not Recruiting

• 2 other identifiers: CAULE 21125GRS 2326/A/21
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Sarcopenic Obesity; Aging

Keywords

obesity; sarcopenia; aging; klotho; miRNA

Outcome Measures

Primary Outcomes (4)

• S-Klotho levels

  2022-2023

• miR-499

  Blood samples

  2022-2023

• cfDNA

  Blood samples

  2022-2023

• Exosomes

  Blood samples

  2022-2023

Secondary Outcomes (4)

• Fat mass

  2022-2023

• Muscle mass

  2022-2023

• Muscle function

  2022-2023

• Muscle function 2

  2022-2023

Study Arms (2)

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

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

Interventions

No intervention, observational study OTHER

No intervention, observational study

control; obesity

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Leon: lead
• Universidad de León: collaborator

Study Sites (1)

Complejo Asistencial Universitario de León

León, 24008, Spain

Location

MeSH Terms

Conditions

Obesity; Sarcopenia

Interventions

Observation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Maria D Ballesteros Pomar, PhD

  Complejo Asistencial Universitario de León

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinical Nutrition Unit, Endocrinology and Nutrition

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: January 19, 2022
• Primary Completion: December 5, 2024
• Study Completion: December 31, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)