Physical Exercise as a Sustainability Tool in Men Affected With Metabolic Syndrome-related Late-onset Central Hypogonadism: Role of Endocrine-metabolic and Neurovegetative Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- change in hypothalamic-pituitary-gonadal axis function
研究概览
简要总结
Aim of this project is to delineate sustainable physical exercise programs and to assess the effects of such programs mainly on endocrine-metabolic and neurovegetative outcomes in a cohort of men with metabolic syndrome-related late-onset central hypogonadism.
Participants will undergo a personalised exercise program. After 6 months they will be subdivided into two groups, according to the weekly physical activity volume actually performed (above or below 600 MET·minutes/week). Changes in endocrine-metabolic and neurovegetative outcomes will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •diagnosis of late-onset central hypogonadism: total T levels < 8 nmol/L (or < 12 nmol/L in the presence of calculated free T < 225 pmol/L) combined with sexual symptoms (erectile dysfunction, low libido and loss of waking erections) [12];
- •diagnosis of metabolic syndrome, defined as association of waist circumference (WC) > 94 cm and at least two among the following criteria: triglycerides ≥ 150 mg/dl, HDL-C < 40 mg/dl, glucose > 100 mg/dl, blood pressure (BP) ≥ 130/85 mmHg [33];
- •ability to give informed consent, in accordance with good clinical practice rules and applicable national laws.
排除标准
- •History of hypothalamus-pituitary organic disorders and/or testicular diseases;
- •impossibility to assess cardiac autonomic regulation due to arrhythmias and/or current treatment for heart rate (HR) control (e.g., beta-blockers, antiarrhythmics);
- •impossibility to undergo clinical assessment;
- •impossibility or contraindications to perform exercise program (for instance, psychiatric disorders, severe musculoskeletal diseases, arrhythmias);
- •inability to give informed consent or unwillingness to be enrolled in the study.
研究组 & 干预措施
weekly physical activity volume performed above 600 MET·minutes/week
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
干预措施: Structured and personalized program of physical exercise (Behavioral)
weekly physical activity volume performed below 600 MET·minutes/week
Exercise program requiring clear definition of modality, intensity, frequency, duration and progression of exercise, tailored on patient's clinical conditions and goals.
干预措施: Structured and personalized program of physical exercise (Behavioral)
结局指标
主要结局
change in hypothalamic-pituitary-gonadal axis function
时间窗: 6 months
particularly testosterone levels (nmol/l)
次要结局
- Change in erythrocyte sedimentation rate(6 months)
- Change in C-reactive protein(6 months)
- Change in glucose profile(6 months)
- Change in nutrition quality(6 months)
- Change in kidney function(6 months)
- Change in total cholesterol(6 months)
- Change in HDL cholesterol(6 months)
- Change in alanine aminotransferase(6 months)
- Change in perception of stress, fatigue, and somatic symptoms(6 months)
- Change in body composition(6 months)
- Change in serum skeletal isoenzyme of alkaline phosphatase(6 months)
- Change in C-terminal telopeptide of type I collagen(6 months)
- Change in triglycerides(6 months)
- Change in aspartate aminotransferase(6 months)
- Change in cardiac autonomic regulation(6 months)
- Change in weekly physical activity volume(6 months)