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

26. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Abdukhalim Kh. Abdurakhimov, PhD
  • Telefonnummer: +998941010091
  • E-post: abduhalim@adti.uz

Studiesteder

  • Usbekistan
      • Andijan, Usbekistan, 170127
        • Rekruttering
        • Andijan State Medical Institute
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Liver Ultrasonographic Morphometry
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Five Times Sit-to-Stand Test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Andijan State Medical Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

8. juli 2026

Først innsendt som oppfylte QC-kriteriene

14. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HYPOMORPH-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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