Predictors of Androgen Status Decline in Middle-Aged Men

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age35-59
SponsorAndijan State Medical Institute

About this trial

Age-related decrease in testosterone levels in men is associated with multiple metabolic, functional and psychosocial consequences. Early identification of modifiable factors associated with decreased testosterone levels may contribute to improved prevention of androgen deficiency and related health conditions.

This population-based analytical cross-sectional observational study aims to investigate anthropometric, functional and lifestyle-related factors associated with decreased 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, standardized questionnaires and laboratory determination of serum total testosterone levels. 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, five-times chair-stand test, 4-meter walk test, balance assessment and the six-minute 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 determinants of decreased testosterone levels and develop a predictive model for early identification of androgen deficiency in middle-aged men.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men aged 35-59 years

Permanent residence in the Andijan region of Uzbekistan

Ability to undergo anthropometric measurements and functional performance tests

Ability to complete study questionnaires

Disqualifiers

Previously diagnosed hypogonadism requiring hormonal therapy

Current testosterone replacement therapy or other medications affecting androgen status

Severe cardiovascular, hepatic or renal diseases in the stage of decompensation

Acute infectious or inflammatory diseases at the time of examination

Trial population

The study population will consist of middle-aged men aged 35-59 years residing in the Andijan region of Uzbekistan. Participants will be recruited through voluntary participation using community-based announcements, primary healthcare institutions, social media platforms and workplace outreach. Eligible participants will undergo standardized anthropometric assessment, functional performance testing, validated questionnaires evaluating lifestyle-related and psychoemotional factors, and laboratory determination of serum total testosterone levels.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observational Assessment

    Other intervention

    Participants undergo standardized anthropometric measurements, functional performance tests, validated questionnaires assessing lifestyle-related and psychoemotional factors, and laboratory determination of serum total testosterone levels. No therapeutic or preventive intervention is administered.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Men with Normal Testosterone Levels1 intervention
Group B: Men with Decreased Testosterone Levels1 intervention

Trial outcomes

Primary outcomes

1

Serum Total Testosterone Level

Serum total testosterone concentration measured in fasting venous blood samples collected between 7:00 and 10:00 AM using standardized immunochemiluminescent assay methods.

Time frame
At baseline

Secondary outcomes

1

Association between body mass index and decreased testosterone levels

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

Time frame
At baseline
2

Association between waist circumference and decreased testosterone levels

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

Time frame
At baseline
3

Association between hand-grip strength and decreased testosterone levels

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

Time frame
At baseline
4

Association between physical activity level and decreased testosterone levels

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

Time frame
At baseline

Other outcomes

Sponsors and contacts

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Andijan State Medical Institute

Lead sponsor

Tashkent Medical Academy

Collaborator

This trial is not recruiting at the moment. You can still explore other options: