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

26. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

  • Usbekistan
      • Andijan, Usbekistan, 170127
        • Rekrutierung
        • Andijan State Medical Institute
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Liver Ultrasonographic Morphometry
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Five Times Sit-to-Stand Test
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Andijan State Medical Institute

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

8. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HYPOMORPH-2026

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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