Predictors of Androgen Status Decline in Middle-Aged Men

NCT07476222 | Recruiting

• 1 other identifier: ANDIJAN-MEN-HEALTH-2026
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Late-Onset Hypogonadism; Androgen Deficiency; Male Hypogonadism; Testosterone Deficiency

Keywords

Testosterone deficiency; Androgen deficiency; Cross-sectional study; Men's health; Sarcopenia; Waist circumference; Body mass index; Sleep quality; Physical activity; Lifestyle factors; Functional status; Anthropometric factors; Middle-aged men; Male hypogonadism; Screening model

Outcome Measures

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).

  At baseline

Secondary Outcomes (5)

• Association between body mass index and decreased testosterone levels

  At baseline

• Association between waist circumference and decreased testosterone levels

  At baseline

• Association between hand-grip strength and decreased testosterone levels

  At baseline

• Association between physical activity level and decreased testosterone levels

  At baseline

• Predictive performance of the integrated screening model for androgen deficiency

  At baseline

Study Arms (2)

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

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

Interventions

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.

Men with Decreased Testosterone Levels; Men with Normal Testosterone Levels

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andijan State Medical Institute: lead
• Tashkent Medical Academy: collaborator

Study Sites (1)

Andijan State Medical Institute

Andijan, 170127, Uzbekistan

RECRUITING

MeSH Terms

Conditions

Eunuchism; Sarcopenia; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavior

Study Officials

• Abdukhalim Kh. Abdurakhimov, PhD

  Andijan State Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdukhalim Kh. Abdurakhimov, PhD

CONTACT

+998941010091; abduhalim@adti.uz

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andijan State Medical Institute

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)