Predictors of Androgen Status Decline in Middle-Aged Men

NCT07476222 | Not Yet Recruiting

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

Brief Summary

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.

Conditions

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

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 7:00 and 10:00 AM using standardized immunochemiluminescent assay methods.

  At baseline

Secondary Outcomes (7)

• 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

• Association between sleep quality and decreased testosterone levels

  At baseline

Study Arms (2)

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

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

Interventions

Observational Assessment OTHER

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Andijan State Medical Institute

Andijan, 170127, Uzbekistan

Location

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: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1)