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NCT Number: NCT07707830

Internal Organ and Musculoskeletal Assessment in Hypothyroidism (HYPOMORPH)

HYPOMORPH is a hospital-based observational cross-sectional study designed to comprehensively characterise internal-organ morphometry and musculoskeletal status in adults with previously diagnosed hypothyroidism receiving routine medical care in Andijan, Uzbekistan.

Approximately 500 adults aged 18-59 years will be included. Participants undergo standardised clinical and anthropometric assessment, ultrasonographic examination of the liver, pancreas and both kidneys, measurement of handgrip strength, and assessment of physical performance using the Five Times Sit-to-Stand Test and 4-m gait speed test. Sarcopenia risk and habitual physical activity are assessed using the SARC-F questionnaire and the International Physical Activity Questionnaire-Short Form (IPAQ-SF), respectively. Serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) concentrations are measured to characterise thyroid functional status at the time of assessment.

The study evaluates ultrasonographic morphometric characteristics of the liver, pancreas and kidneys and musculoskeletal functional characteristics, and investigates their associations with thyroid-related, anthropometric, clinical and laboratory variables. Multivariable regression analyses will be used to identify factors independently associated with organ-specific morphometric and functional outcomes.

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Key information

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Andijan State Medical Institute

Andijan, 170127, Uzbekistan

Location status: Recruiting

Location contact

Abdukhalim Kh. Abdurakhimov, PhD

CONTACT

[email protected]

+9988941010091

About this study

Hypothyroidism is associated with systemic manifestations extending beyond the thyroid gland, including hepatic, renal, pancreatic and musculoskeletal alterations. Previous studies have predominantly evaluated individual organs, metabolic outcomes or isolated components of physical function. Concurrent standardised assessment of multiple-organ morphometry, anthropometry, muscle strength and physical performance within the same population remains limited, particularly in Central Asian populations.

HYPOMORPH is a hospital-based observational cross-sectional study conducted among adults aged 18-59 years with a previously established diagnosis of hypothyroidism who are receiving routine outpatient or inpatient care at participating healthcare institutions in Andijan, Uzbekistan.

The study uses an integrated assessment of internal-organ morphometry and musculoskeletal status. Internal-organ assessment includes standardised ultrasonographic evaluation of the liver, pancreas and both kidneys. Musculoskeletal assessment includes anthropometric measurements, handgrip strength and objective physical performance testing using the Five Times Sit-to-Stand Test and 4-m gait speed test. Sarcopenia risk is assessed using the SARC-F questionnaire, and habitual physical activity is assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).

Clinical and treatment-related characteristics, including duration of hypothyroidism and levothyroxine therapy, are recorded. Serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) concentrations are measured to characterise thyroid functional status at the time of assessment.

The study aims to characterise organ-specific morphometric and musculoskeletal features in adults with hypothyroidism and to investigate their relationships with thyroid-related, anthropometric, clinical and functional characteristics. Multivariable analyses will be used to evaluate factors independently associated with organ-specific morphometric and functional outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-59 years.
  • Previously established diagnosis of hypothyroidism.
  • Receiving routine outpatient or inpatient care at participating healthcare institutions.
  • Ability to undergo ultrasonographic, anthropometric and functional assessments.
  • Provision of written informed consent.

Exclusion criteria

  • Pregnancy or lactation.
  • History of thyroid malignancy.
  • Acute infectious or inflammatory disease at the time of enrolment.
  • Severe decompensated cardiovascular, hepatic or renal disease preventing study procedures.
  • Neurological or musculoskeletal disorders that preclude functional testing.
  • Refusal or inability to provide written informed consent.

Treatment and study plan

Comprehensive Morphometric and Functional Assessment

Other

Participants undergo a standardised study assessment including clinical evaluation, anthropometric measurements, ultrasonographic examination of the liver, pancreas and both kidneys, handgrip strength measurement, the Five Times Sit-to-Stand Test, 4-m gait speed assessment, physical activity and sarcopenia screening, and laboratory measurement of serum TSH and FT4. No therapeutic intervention or modification of routine clinical management is involved.

Primary outcomes

  1. Liver Ultrasonographic Morphometry

    Time frame: Baseline

    Ultrasonographic assessment of the liver will include predefined linear morphometric measurements obtained using standardised anatomical landmarks and measurement procedures. Measurements will be recorded in millimetres (mm). Organ-specific morphological characteristics, including liver contours, echogenicity and echostructure, will be recorded as complementary ultrasonographic characteristics.

  2. Pancreatic Ultrasonographic Morphometry

    Time frame: Baseline

    Ultrasonographic assessment of the pancreas will include anteroposterior measurements of the pancreatic head, body and tail using standardised anatomical landmarks and measurement procedures. Measurements will be recorded in millimetres (mm). Pancreatic echogenicity and echostructure will be recorded as complementary ultrasonographic characteristics.

  3. Renal Ultrasonographic Morphometry

    Time frame: Baseline

    Both kidneys will be assessed separately by ultrasonography. Longitudinal, transverse and anteroposterior dimensions will be measured using standardised anatomical landmarks and measurement procedures and recorded in millimetres (mm). Relevant renal parenchymal characteristics will be recorded as complementary ultrasonographic characteristics.

Secondary outcomes

  1. Five Times Sit-to-Stand Test

    Time frame: Baseline

    Lower-extremity physical function will be assessed using the Five Times Sit-to-Stand Test. The time required to complete five consecutive chair stands without using the arms will be recorded in seconds. Longer completion times indicate poorer physical performance.

  2. 4-m Gait Speed

    Time frame: Baseline

    Physical performance will be assessed using the 4-m gait speed test according to a standardised protocol. Gait speed will be calculated in metres per second (m/s), with higher values indicating faster walking speed.

  3. Anthropometric Characteristics

    Time frame: Baseline

    Anthropometric assessment will include body mass index (BMI), waist circumference, hip circumference, peripheral body circumferences, waist-to-hip ratio (WHR) and waist-to-height ratio (WHtR), measured or calculated according to standardised procedures.

  4. Handgrip Strength

    Time frame: Baseline

    Muscle strength will be assessed using handgrip dynamometry according to a standardised measurement protocol. Maximum handgrip strength will be recorded in kilograms (kg), with higher values indicating greater muscle strength.

  5. SARC-F Score

    Time frame: Baseline

    Sarcopenia risk will be assessed using the SARC-F questionnaire. The total SARC-F score will be calculated according to the standard scoring procedure, with higher scores indicating greater risk of sarcopenia.

  6. Physical Activity Assessed by IPAQ-SF

    Time frame: Baseline

    Habitual physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Information on walking, moderate-intensity physical activity, vigorous-intensity physical activity and sedentary time will be collected, and physical activity variables will be derived according to established IPAQ scoring procedures.

  7. Serum Thyroid-Stimulating Hormone (TSH)

    Time frame: Baseline

    Serum thyroid-stimulating hormone (TSH) concentration will be measured using an automated chemiluminescent immunoassay to characterise thyroid functional status at the time of study assessment.

  8. Serum Free Thyroxine (FT4)

    Time frame: Baseline

    Serum free thyroxine (FT4) concentration will be measured using an automated chemiluminescent immunoassay to characterise thyroid functional status at the time of study assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdukhalim Kh. Abdurakhimov, PhD

CONTACT

[email protected]

+998941010091

Sponsors and collaborators

Lead sponsor

Andijan State Medical Institute

Other

Registry information

Official study title

Morphometric Characteristics of Internal Organs and Morphofunctional Status of the Musculoskeletal System in Patients With Hypothyroidism

Acronym: HYPOMORPH

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 16, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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