Hypothyroidism
Conditions
Keywords
Hypothyroidism, Ultrasonography, Morphometry, Liver, Pancreas, Kidney, Musculoskeletal System, Anthropometry, Muscle Strength, Handgrip Strength, Physical Function, Physical Activity, Sarcopenia, Thyroid-Stimulating Hormone, Cross-Sectional Study
Brief summary
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.
Detailed description
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.
Interventions
OTHERComprehensive Morphometric and Functional Assessment
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.
Sponsors
Andijan State Medical Institute
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Ultrasonographic Morphometry | 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. |
| Liver Ultrasonographic Morphometry | 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. |
| Pancreatic Ultrasonographic Morphometry | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Assessed by IPAQ-SF | 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. |
| Serum Thyroid-Stimulating Hormone (TSH) | 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. |
| Serum Free Thyroxine (FT4) | 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. |
| Five Times Sit-to-Stand Test | 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. |
| Anthropometric Characteristics | 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-m Gait Speed | 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. |
| Handgrip Strength | 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. |
| SARC-F Score | 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. |
Countries
Uzbekistan
Contacts
CONTACTAbdukhalim Kh. Abdurakhimov, PhD
Outcome results
None listed