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Internal Organ and Musculoskeletal Assessment in Hypothyroidism (HYPOMORPH)

ConditionHypothyroidism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-59
SponsorAndijan State Medical Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adults aged 18-59 years with a previously established diagnosis of hypothyroidism who are receiving routine outpatient or inpatient medical care at participating healthcare institutions in Andijan, Uzbekistan.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Comprehensive Morphometric and Functional Assessment

    Other intervention

    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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients With Hypothyroidism1 intervention

Trial outcomes

Primary outcomes

1

Liver Ultrasonographic Morphometry

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.

Time frame
Baseline
2

Pancreatic Ultrasonographic Morphometry

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.

Time frame
Baseline
3

Renal Ultrasonographic Morphometry

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.

Time frame
Baseline

Secondary outcomes

1

Five Times Sit-to-Stand Test

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.

Time frame
Baseline
2

4-m Gait Speed

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.

Time frame
Baseline
3

Anthropometric Characteristics

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.

Time frame
Baseline
4

Handgrip Strength

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andijan State Medical Institute

Lead sponsor

Source ClinicalTrials.gov
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