Anthropometric, Functional and Lifestyle Factors Associated With Testosterone Levels in Middle-Aged Men (TESMEN)

August 22, 2026 updated by: Abdukhalim Kh. Abdurakhimov, PhD, Andijan State Medical Institute

Anthropometric, Functional and Lifestyle-related Factors Associated With Testosterone Levels Among Middle-aged Men in Uzbekistan: Protocol for a Population-based Cross-sectional Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abdukhalim Kh. Abdurakhimov, PhD
  • Phone Number: +998941010091
  • Email: abduhalim@adti.uz

Study Locations

  • Uzbekistan
      • Andijan, Uzbekistan, 170127
        • Recruiting
        • Andijan State Medical Institute
        • Contact:
          • Abdukhalim Kh. Abdurakhimov, PhD
          • Phone Number: +998941010091
          • Email: abduhalim@adti.uz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Men with Normal Testosterone Levels
Participants classified after baseline laboratory assessment as having serum total testosterone concentrations within the laboratory reference range.
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.
Men with Decreased Testosterone Levels
Participants classified after baseline laboratory assessment as having decreased serum total testosterone concentrations according to predefined laboratory reference criteria.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between anthropometric characteristics and serum total testosterone levels
Time Frame: At baseline
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).
At baseline
Correlation between functional parameters and serum total testosterone levels
Time Frame: At baseline
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).
At baseline
Correlation between physical activity and serum total testosterone levels
Time Frame: At baseline
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.
At baseline
Correlation between sleep duration and serum total testosterone levels
Time Frame: At baseline
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.
At baseline
Association between smoking status and serum total testosterone levels
Time Frame: At baseline
Serum total testosterone concentration (nmol/L) will be assessed in relation to self-reported smoking status using the structured study questionnaire. Participants will be classified as never smokers, former smokers, or current smokers. Differences in serum total testosterone levels across smoking-status categories will be evaluated using appropriate statistical methods.
At baseline
Association between alcohol consumption status and serum total testosterone levels
Time Frame: At baseline
Serum total testosterone concentration (nmol/L) will be assessed in relation to self-reported alcohol consumption status using the structured study questionnaire. Participants will be classified as non-drinkers, former drinkers, or current drinkers. Differences in serum total testosterone levels across alcohol-consumption categories will be evaluated using appropriate statistical methods.
At baseline
Independent factors associated with decreased serum total testosterone levels
Time Frame: At baseline
Independent anthropometric, functional and lifestyle-related factors associated with decreased serum total testosterone will be evaluated using multivariable logistic regression analysis. Decreased serum total testosterone will be defined according to the prespecified clinically relevant threshold described in the study protocol, and associations will be reported as adjusted odds ratios (ORs) with 95% confidence intervals (CIs). In complementary analyses, serum total testosterone concentration (nmol/L) will be analysed as a continuous outcome using multivariable linear regression, with regression coefficients and 95% CIs reported.
At baseline
Development and internal validation of a multivariable predictive model for decreased serum total testosterone
Time Frame: At baseline
A multivariable predictive model based on anthropometric, functional and lifestyle-related factors will be developed for identification of men with decreased serum total testosterone, defined according to the prespecified clinically relevant threshold. Model discrimination will be quantified using the area under the receiver operating characteristic curve (AUC; range 0-1), with sensitivity and specificity reported as appropriate. Calibration will be assessed using calibration plots and appropriate statistical measures. Internal validation will be performed using bootstrap resampling (1000 samples) to estimate optimism and assess model stability and potential overfitting.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andijan State Medical Institute

Collaborators

Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

Investigators

  • Principal Investigator: Abdukhalim Kh. Abdurakhimov, PhD, Andijan State Medical Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANDIJAN-MEN-HEALTH-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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