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NCT Number: NCT07476222

Predictors of Androgen Status Decline in Middle-Aged Men

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Assessment

Other

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 outcomes

  1. Serum Total Testosterone Level

    Time frame: 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).

Secondary outcomes

  1. Association between body mass index and decreased testosterone levels

    Time frame: At baseline

    Assessment of the association between body mass index and decreased serum total testosterone levels.

  2. Association between waist circumference and decreased testosterone levels

    Time frame: At baseline

    Evaluation of abdominal obesity assessed by waist circumference as a factor associated with decreased serum total testosterone levels.

  3. Association between hand-grip strength and decreased testosterone levels

    Time frame: At baseline

    Assessment of hand-grip strength as a functional indicator associated with serum total testosterone levels.

  4. Association between physical activity level and decreased testosterone levels

    Time frame: At baseline

    Assessment of physical activity level using the International Physical Activity Questionnaire (IPAQ) and its association with decreased serum total testosterone levels.

  5. Predictive performance of the integrated screening model for androgen deficiency

    Time frame: At baseline

    Evaluation of the diagnostic performance of the integrated screening model based on anthropometric, functional and lifestyle-related variables using ROC analysis, including sensitivity, specificity and area under the curve (AUC).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdukhalim Kh. Abdurakhimov, PhD

CONTACT

[email protected]

+998941010091

Sponsors and collaborators

Lead sponsor

Andijan State Medical Institute

Other

Collaborators

  • Tashkent Medical Academy

Registry information

Official study 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

Acronym: TESMEN

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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