Predictors of Androgen Status Decline in Middle-Aged Men (TESMEN)

Anthropometric, Functional and Lifestyle Determinants of Decreased Testosterone Levels in Middle-Aged Men: A Population-Based Cross-Sectional Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Male Hypogonadism; Testosterone Deficiency; Androgen Deficiency; Late-Onset Hypogonadism
• Intervention / Treatment: Other: Observational Assessment

Detailed Description

Testosterone plays an important role in maintaining male reproductive health, body composition, muscle strength and metabolic homeostasis. Age-related decrease in testosterone levels has been associated with increased risk of metabolic syndrome, obesity, type 2 diabetes mellitus, cardiovascular diseases, reduced physical performance and impaired quality of life. Despite increasing recognition of androgen deficiency as an important public health issue, many cases remain undiagnosed because of nonspecific clinical manifestations.

Previous studies have demonstrated that obesity, physical inactivity, poor sleep quality, unhealthy dietary patterns and harmful lifestyle habits may influence testosterone levels. However, the complex interactions between anthropometric characteristics, functional status and lifestyle-related determinants remain insufficiently investigated, particularly in population-based studies conducted in middle-aged men.

The present study is designed as a population-based analytical cross-sectional observational study aimed at identifying anthropometric, functional and lifestyle determinants of decreased total testosterone levels in middle-aged men.

Approximately 600 men aged 35-59 years living in the Andijan region of Uzbekistan will be recruited. Participants will undergo anthropometric assessment including height, body weight, body mass index, waist circumference, hip circumference, waist-to-hip ratio and waist-to-height ratio. Functional performance will be evaluated using hand-grip dynamometry, five-times chair-stand test, 4-meter walk test, balance test and six-minute walk test.

Lifestyle-related characteristics will be assessed using standardized questionnaires including the International Physical Activity Questionnaire (IPAQ), Pittsburgh Sleep Quality Index (PSQI), Food Frequency Questionnaire (FFQ), Hospital Anxiety and Depression Scale (HADS), Aging Males' Symptoms Scale (AMS), Androgen Deficiency in Aging Males questionnaire (ADAM) and SARC-F questionnaire. Additional information regarding smoking status, alcohol consumption, occupational characteristics and comorbidities will also be collected.

Venous blood samples will be collected between 7:00 and 10:00 AM following overnight fasting to determine serum total testosterone levels using standardized laboratory methods.

Statistical analysis will include correlation analysis, multivariable logistic regression and receiver operating characteristic (ROC) analysis to identify independent determinants of decreased testosterone levels. Based on the obtained results, a predictive screening model for early identification of androgen deficiency in middle-aged men will be developed.

The results of this study may contribute to improved understanding of modifiable determinants of testosterone deficiency and support development of preventive strategies aimed at improving men's health.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

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

Study Locations

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

Participation Criteria

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 standardized anthropometric assessment, functional performance testing, validated questionnaires evaluating lifestyle-related and psychoemotional factors, and laboratory determination of serum total testosterone levels.

Description

Inclusion Criteria:

• 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
• Provision of written informed consent

Exclusion Criteria:

• 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
• Severe psychiatric or cognitive disorders limiting participation
• Clinically significant urological pathology
• Inability or unwillingness to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between body mass index and decreased testosterone levels	Assessment of the association between body mass index and decreased serum total testosterone levels.	At baseline
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.	At baseline
Association between hand-grip strength and decreased testosterone levels	Assessment of hand-grip strength as a functional indicator associated with serum total testosterone levels.	At baseline
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.	At baseline
Association between sleep quality and decreased testosterone levels	Assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and its association with decreased serum total testosterone levels.	At baseline
Association between psychoemotional status and decreased testosterone levels	Assessment of anxiety and depressive symptoms using the Hospital Anxiety and Depression Scale (HADS) and their association with decreased serum total testosterone levels.	At baseline
Predictive performance of the integrated screening model for androgen deficiency	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).	At baseline

Collaborators and Investigators

• Sponsor: Andijan State Medical Institute
• Collaborators: Tashkent Medical Academy
• Investigators: Principal Investigator: Abdukhalim Kh. Abdurakhimov, PhD, Andijan State Medical Institute

Study record dates

Study Major Dates

• Study Start (Estimated): 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): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physical activity; Sarcopenia; Functional status; Sleep quality; Men's health; Lifestyle factors; Body mass index; Waist circumference; Testosterone deficiency; Cross-sectional study; Androgen deficiency; Male hypogonadism; Middle-aged men; Anthropometric factors; Screening model
• Additional Relevant MeSH Terms: Neurologic Manifestations; Endocrine System Diseases; Nervous System Diseases; Neuromuscular Manifestations; Mental Disorders; Pathological Conditions, Anatomical; Sleep Wake Disorders; Gonadal Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Muscular Atrophy; Atrophy; Hypogonadism; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Sarcopenia; Eunuchism; Motor Activity
• 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