Anthropometric, Functional and Lifestyle-related Factors Associated With Testosterone Levels Among Middle-aged Men in Uzbekistan: Protocol for a Population-based Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Serum Total Testosterone Level
研究概览
简要总结
Decreased testosterone levels in middle-aged men are associated with multiple metabolic, functional and psychosocial consequences. Early identification of modifiable factors associated with reduced testosterone levels may facilitate the early identification of men at increased risk of testosterone deficiency and support preventive healthcare strategies.
This population-based cross-sectional observational study aims to investigate anthropometric, functional and lifestyle-related factors associated with serum total testosterone levels in middle-aged men. Approximately 600 men aged 35-59 years residing in the Andijan region of Uzbekistan will be recruited.
Participants will undergo comprehensive assessment including anthropometric measurements, functional performance tests, standardised questionnaires and laboratory determination of serum total testosterone concentrations. Anthropometric variables will include body mass index, waist circumference, hip circumference, waist-to-hip ratio and waist-to-height ratio. Functional status will be assessed using hand-grip strength, the five-times chair-stand test and the 4-m walk test. Lifestyle-related factors will be assessed using standardised and study-specific questionnaires. Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), while dietary habits, sleep characteristics, smoking status, alcohol consumption and psychosocial characteristics will be assessed using a structured study questionnaire.
The study aims to identify factors associated with serum total testosterone levels and to develop a predictive model for the early identification of men at increased risk of testosterone deficiency.
详细描述
Testosterone plays an important role in maintaining male reproductive health, body composition, muscle strength and metabolic homeostasis. Reduced testosterone levels in middle-aged men have been associated with an increased risk of metabolic syndrome, obesity, type 2 diabetes mellitus, cardiovascular diseases, reduced physical performance and impaired quality of life. Despite increasing recognition of testosterone deficiency as an important public health issue, many cases remain unrecognised because of nonspecific clinical manifestations.
Previous studies have demonstrated that obesity, physical inactivity, poor sleep quality, unhealthy dietary patterns and other lifestyle-related factors may influence serum testosterone levels. However, the combined associations of anthropometric characteristics, functional status and lifestyle-related factors with serum testosterone levels remain insufficiently investigated, particularly in population-based studies involving middle-aged men.
The present study is designed as a population-based cross-sectional observational study aimed at investigating anthropometric, functional and lifestyle-related factors associated with serum total testosterone levels in middle-aged men.
Approximately 600 men aged 35-59 years residing in the Andijan region of Uzbekistan will be recruited. Participants will undergo comprehensive assessment including anthropometric measurements, functional performance tests, standardised questionnaires and laboratory determination of serum total testosterone concentrations. Anthropometric variables will include height, body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio and waist-to-height ratio. Functional performance will be assessed using hand-grip strength, the five-times chair-stand test and the 4-m walk test.
Lifestyle-related characteristics will be evaluated using validated questionnaires assessing physical activity, sleep quality, dietary habits, lower urinary tract symptoms, symptoms suggestive of testosterone deficiency and muscle function. Additional information regarding smoking status, alcohol consumption, occupational characteristics, medical history and comorbidities will also be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 35-59 years
- •Permanent residence in the Andijan region of Uzbekistan
- •Ability and willingness to provide written informed consent
- •Willingness to undergo clinical, anthropometric, functional and laboratory assessments
排除标准
- •Previously diagnosed hypogonadism requiring testosterone replacement therapy
- •Current use of testosterone preparations or other medications known to substantially affect androgen status
- •Severe cardiovascular, hepatic or renal disease in the stage of decompensation
- •Clinically significant urological pathology
- •Severe psychiatric illness or cognitive impairment limiting study participation
- •Acute infectious or inflammatory conditions at the time of assessment
研究组 & 干预措施
Men with Normal Testosterone Levels
Participants classified after baseline laboratory assessment as having serum total testosterone concentrations within the laboratory reference range.
干预措施: Observational Assessment (Other)
Men with Decreased Testosterone Levels
Participants classified after baseline laboratory assessment as having decreased serum total testosterone concentrations according to predefined laboratory reference criteria.
干预措施: Observational Assessment (Other)
结局指标
主要结局
Serum Total Testosterone Level
时间窗: At baseline
Serum total testosterone concentration measured in fasting venous blood samples collected between 08:00 and 10:00 hours using a chemiluminescent microparticle immunoassay (CMIA) on the ARCHITECT i1000SR immunoassay analyser (Abbott Laboratories, Abbott Park, IL, USA).
次要结局
- Association between body mass index and decreased testosterone levels(At baseline)
- Association between waist circumference and decreased testosterone levels(At baseline)
- Association between anthropometric characteristics and serum total testosterone levels(At baseline)
- Association between functional parameters and serum total testosterone levels(At baseline)
- Association between lifestyle-related factors and serum total testosterone levels(At baseline)
- Independent factors associated with decreased testosterone levels(At baseline)
- Development and internal validation of a multivariable predictive model for testosterone deficiency(At baseline)
- Correlation between anthropometric characteristics and serum total testosterone levels(At baseline)
- Correlation between functional parameters and serum total testosterone levels(At baseline)
- Correlation between physical activity and serum total testosterone levels(At baseline)
- Correlation between sleep duration and serum total testosterone levels(At baseline)
- Association between smoking status and serum total testosterone levels(At baseline)
- Association between alcohol consumption status and serum total testosterone levels(At baseline)
- Independent factors associated with decreased serum total testosterone levels(At baseline)
- Development and internal validation of a multivariable predictive model for decreased serum total testosterone(At baseline)
- Association between hand-grip strength and decreased testosterone levels(At baseline)
研究者
Abdukhalim Kh. Abdurakhimov, PhD
Andijan State Medical Institute
Andijan State Medical Institute