NCT04186767已完成不适用
Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Seminal evaluation
研究概览
简要总结
This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Obesity in male patients
- •Metabolic Syndrome (NCEP-ATP III)
- •Alteration of some of the seminal parameters evaluated in conventional seminal analysis
排除标准
- •Other causes of hypogonadotrophic hypogonadism
- •Hypergonadotrophic hypogonadism
- •Contraindications for performance of ketogenic diet:
- •Type 1 or type 2 diabetes mellitus in insulin use
- •Food drive
- •Alcoholism or drug addiction
- •Severe psychiatric illness
- •Use of coumarin anticoagulants
- •Hepatic insufficiency
- •Severe renal impairment
- •Hematologic diseases
- •Cancer in activity,
- •Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke)
- •Renal or biliary lithiasis
- •Major depression or other serious psychiatric illness.
结局指标
主要结局
Seminal evaluation
时间窗: Six months
Spermatic counting will be combined to report
次要结局
- Inflamatory response(Six months)
- Epigenetic evaluation(Six months)
- Brow tissue study(Six months)
- Adipose tissue toxins study(Six months)
- Microbiota evaluation(Six months)
- Body composition changes(Six months)
- Metabolic response(Six months)
- Hormonal measurements(Six months)
- Adipose tissue evaluation(Six months)
研究者
Alessandra Renck
Principal Investigator
University of Sao Paulo
研究点 (2)
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