Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
75 participants
OBSERVATIONAL
2022-01-19
2024-12-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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obesity
Patients with obesity attended in the High-Risk Obesity clinic of the Complejo ASistencial Universitario de León, 50-60 years-old
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
No intervention, observational study
No intervention, observational study
Interventions
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No intervention, observational study
No intervention, observational study
Eligibility Criteria
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Inclusion Criteria
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
Active cancer disease. Heart or respiratory failure requiring pharmacological treatment.
50 Years
60 Years
ALL
Yes
Sponsors
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Universidad de León
OTHER
Hospital de Leon
OTHER_GOV
Responsible Party
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Maria D. Ballesteros Pomar
Head of Clinical Nutrition Unit, Endocrinology and Nutrition
Principal Investigators
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Maria D Ballesteros Pomar, PhD
Role: STUDY_DIRECTOR
Complejo Asistencial Universitario de León
Locations
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Complejo Asistencial Universitario de León
León, , Spain
Countries
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Other Identifiers
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GRS 2326/A/21
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CAULE 21125
Identifier Type: -
Identifier Source: org_study_id
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