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Internal Organ and Musculoskeletal Assessment in Hypothyroidism (HYPOMORPH) (HYPOMORPH)

26 augustus 2026 bijgewerkt door: Andijan State Medical Institute

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

500

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Abdukhalim Kh. Abdurakhimov, PhD
  • Telefoonnummer: +998941010091
  • E-mail: abduhalim@adti.uz

Studie Locaties

  • Oezbekistan
      • Andijan, Oezbekistan, 170127
        • Werving
        • Andijan State Medical Institute
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Patients With Hypothyroidism
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. Participants undergo standardised clinical and anthropometric assessment, ultrasonographic evaluation of the liver, pancreas and both kidneys, musculoskeletal functional assessment and laboratory testing according to the study protocol.
Ander: Comprehensive 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Liver Ultrasonographic Morphometry
Tijdsspanne: 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.
Baseline
Pancreatic Ultrasonographic Morphometry
Tijdsspanne: 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.
Baseline
Renal Ultrasonographic Morphometry
Tijdsspanne: 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.
Baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Five Times Sit-to-Stand Test
Tijdsspanne: 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.
Baseline
4-m Gait Speed
Tijdsspanne: 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.
Baseline
Anthropometric Characteristics
Tijdsspanne: 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.
Baseline
Handgrip Strength
Tijdsspanne: 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.
Baseline
SARC-F Score
Tijdsspanne: 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.
Baseline
Physical Activity Assessed by IPAQ-SF
Tijdsspanne: 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.
Baseline
Serum Thyroid-Stimulating Hormone (TSH)
Tijdsspanne: 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.
Baseline
Serum Free Thyroxine (FT4)
Tijdsspanne: 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.
Baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Andijan State Medical Institute

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

8 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juli 2026

Eerst geplaatst (Werkelijk)

16 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HYPOMORPH-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data that underlie the published results may be made available from the corresponding author upon reasonable request following completion of the study and publication of the primary results. Data sharing will be subject to ethical approval, participant confidentiality requirements, applicable institutional policies and any necessary data-sharing agreements. Requests will be considered on the basis of their scientific purpose and compliance with applicable ethical and data-protection requirements.

IPD-tijdsbestek voor delen

De-identified IPD and supporting information will become available after publication of the primary study results and will remain available for 5 years thereafter.

IPD-toegangscriteria voor delen

De-identified IPD and supporting information may be provided to qualified researchers upon reasonable request to the corresponding author. Requests should include a scientifically justified research proposal and will be reviewed for scientific purpose and compliance with ethical, confidentiality, institutional and data-protection requirements. A data-sharing agreement may be required before access is granted.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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