Evaluation of Endothelial and Vascular Functions in Obese Patients: Analysis of the Blood Flow in the Femoral Artery During Passive Movements of the Limbs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from baseline in blood flow in the femoral artery in Cases
研究概览
简要总结
The primary objective of the present study will be to evaluate, in obese patients, the blood flow response in the femoral artery in response to passive limb movements, taken as a biomarker of a possible limitation of the peripheral vascular-endothelial-microvascular function. The values will be compared with those obtained in normal subjects, in patients with cardiovascular (Gilford & Richardson 2017) or respiratory diseases (Ives et al. 2020), and in healthy subjects subjected to bed rest (Zuccarelli et al. 2020).
The data of the recruited obese patients will be obtained at the beginning and the end of the standard rehabilitation period (including calorie reduction interventions, physical exercise, and psychological counseling) conducted over 3 weeks at the Division of Auxology, Istituto Auxologico Italiano, Piancavallo, Italy. A secondary objective will be to evaluate any changes following the rehabilitation program on the patients' endothelial-peripheral-vascular-microvascular function. The data obtained will also be evaluated in comparison with hematochemical and molecular indices for evaluating the endothelial function, as well as with standard parameters for the overall functional evaluation of the oxidative function and the ability to sustain exercise ("peak" O2 consumption during exercise, thresholds anaerobic diseases.
详细描述
Materials and methods:
The study will be attended by 15 young obese males aged between 15 and 40 years recruited at the Division of Auxology (minors) and the Division of Metabolic Diseases (adults), Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy.
The inclusion criteria for the study group will be:
- BMI > 97th percentile for age and gender (minors) and >35 (adults).
- not having done structured physical activity programs (regular activity for more than 120 min/week) during the 6 months preceding the study.
- absence of pathologies such as diabetes or insulin resistance.
- absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal or musculoskeletal pathologies contraindicated for carrying out the tests.
Furthermore, 15 male control subjects of similar age, with normal BMI, will be recruited among friends and colleagues from the Department of Medical Area, University of Udine, who will have to satisfy the inclusion criteria 2-4 mentioned above.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •BMI > 97th percentile for age and gender (minors) and >35 (adults).
- •not having done structured physical activity programs (regular activity for more than 120 min/week) during the 6 months preceding the study.
- •absence of pathologies such as diabetes or insulin resistance.
- •absence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal or musculoskeletal pathologies contraindicated for carrying out the tests.
排除标准
- •having done structured physical activity programs (regular activity for more than 120 min/week) during the 6 months preceding the study
- •presence of diabetes or insulin resistance
- •presence of signs/symptoms referable to cardiovascular, respiratory, gastrointestinal or musculoskeletal pathologies contraindicated for carrying out the tests.
结局指标
主要结局
Change from baseline in blood flow in the femoral artery in Cases
时间窗: At baseline and at end of test, before and after 3 weeks of body weight reduction program
Change from baseline in blood flow in the femoral artery to Passive knee flexion-extension + Cycle ergometer exercise
Change from baseline in blood flow in the femoral artery in Controls
时间窗: At baseline and at end of test
Change from baseline in blood flow in the femoral artery to Passive knee flexion-extension + Cycle ergometer exercise
次要结局
- Evaluation of variables of endothelial function and inflammation markers - CRP(Baseline and after 3 weeks)
- Evaluation of variables of endothelial function and inflammation markers - IL-6(Baseline and after 3 weeks)