Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age35-59
SponsorAndijan State Medical Institute
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
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 a comprehensive assessment including standardized anthropometric measurements, functional performance tests, validated questionnaires assessing lifestyle-related factors and symptoms suggestive of testosterone deficiency, and laboratory determination of serum total testosterone concentrations.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Observational Assessment
Other interventionParticipants 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup 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 08:00 and 10:00 hours using a chemiluminescent microparticle immunoassay (CMIA) on the ARCHITECT i1000SR immunoassay analyser (Abbott Laboratories, Abbott Park, IL, USA).
Time frame
At baselineSecondary outcomes
1
Correlation between anthropometric characteristics and serum total testosterone levels
Correlations between serum total testosterone concentration (nmol/L) and anthropometric characteristics will be assessed using Pearson or Spearman correlation coefficients, as appropriate. Anthropometric measures include body mass index (BMI, kg/m²), waist circumference (cm), hip circumference (cm), waist-to-hip ratio (dimensionless), and waist-to-height ratio (dimensionless).
Time frame
At baseline2
Correlation between functional parameters and serum total testosterone levels
Correlations between serum total testosterone concentration (nmol/L) and functional parameters will be assessed using Pearson or Spearman correlation coefficients, as appropriate. Functional measures include maximal hand-grip strength measured by hand dynamometry (kg), five-times chair-stand test completion time (seconds), and 4-m gait speed (m/s).
Time frame
At baseline3
Correlation between physical activity and serum total testosterone levels
Correlation between serum total testosterone concentration (nmol/L) and physical activity level assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), expressed as total physical activity in MET-minutes/week, will be evaluated using Pearson or Spearman correlation coefficients, as appropriate.
Time frame
At baseline4
Correlation between sleep duration and serum total testosterone levels
Correlation between serum total testosterone concentration (nmol/L) and self-reported sleep duration (hours per night), assessed using the structured study questionnaire, will be evaluated using Pearson or Spearman correlation coefficients, as appropriate. The correlation will be reported as Pearson's r or Spearman's ρ.
Time frame
At baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andijan State Medical Institute
Lead sponsor
Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
Collaborator
Source ClinicalTrials.gov