SARCOBEAGING: Sarcopenic Obesity as a Risk of Premature Aging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Exosomes
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Premenopausal women. Kidney disease with glomerular filtration rate less than
- •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.
结局指标
主要结局
Exosomes
时间窗: 2022-2023
Blood samples
S-Klotho levels
时间窗: 2022-2023
miR-499
时间窗: 2022-2023
Blood samples
cfDNA
时间窗: 2022-2023
Blood samples
次要结局
- Muscle function(2022-2023)
- Muscle function 2(2022-2023)
- Fat mass(2022-2023)
- Muscle mass(2022-2023)
研究者
Maria D. Ballesteros Pomar
Head of Clinical Nutrition Unit, Endocrinology and Nutrition
Hospital de Leon