Internal Organ and Musculoskeletal Assessment in Hypothyroidism (HYPOMORPH)
NCT07707830
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.
Eligibility
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.
Conditions2
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NCT07707830