Predictors of Androgen Status Decline in Middle-Aged Men
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational Assessment.
- Who it may be relevant to
- Registry conditions: Testosterone Deficiency, Androgen Deficiency, Male Hypogonadism, Late-Onset Hypogonadism. Basic parameters: 35 years — 59 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uzbekistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Anthropometric, Functional and Lifestyle-related Factors Associated With Testosterone Levels Among Middle-aged Men in Uzbekistan: Protocol for a Population-based Cross-sectional Study
Overview
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 including physical activity, sleep quality, dietary habits, smoking, alcohol consumption and psychoemotional status will be evaluated using validated questionnaires. 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.
Detailed description
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.
Venous blood samples will be collected between 08:00 and 10:00 hours following an overnight fast. Serum total testosterone concentrations will be measured using standardised laboratory procedures.
Statistical analyses will include correlation analyses, multivariable linear and logistic regression models, and receiver operating characteristic (ROC) curve analysis to identify factors associated with serum total testosterone levels and decreased total testosterone levels. Based on the study findings, a multivariable predictive model will be developed for the early identification of men at increased risk of testosterone deficiency.
The findings of this study are expected to improve understanding of anthropometric, functional and lifestyle-related factors associated with serum total testosterone levels and to support the development of accessible risk assessment strategies for the early identification of testosterone deficiency in middle-aged men.
Interventions
- Other Observational Assessment
Participants undergo standardised anthropometric measurements, functional performance tests, validated questionnaires assessing lifestyle-related factors, lower urinary tract symptoms, symptoms suggestive of testosterone deficiency and muscle function, together with laboratory determination of serum total testosterone concentrations. No therapeutic or preventive intervention is administered.
Primary outcome measures
- Serum Total Testosterone Level [Time frame: At baseline]
Secondary outcome measures (5)
- Association between body mass index and decreased testosterone levels [Time frame: At baseline]
- Association between waist circumference and decreased testosterone levels [Time frame: At baseline]
- Association between hand-grip strength and decreased testosterone levels [Time frame: At baseline]
- Association between physical activity level and decreased testosterone levels [Time frame: At baseline]
- Predictive performance of the integrated screening model for androgen deficiency [Time frame: At baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Uzbekistan · 1 center
- Andijan State Medical Institute — Andijan
Identifiers
NCT: NCT07476222 · ANDIJAN-MEN-HEALTH-2026