- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07707830
Internal Organ and Musculoskeletal Assessment in Hypothyroidism (HYPOMORPH) (HYPOMORPH)
Morphometric Characteristics of Internal Organs and Morphofunctional Status of the Musculoskeletal System in Patients With Hypothyroidism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Hypothyroidism is one of the most common endocrine disorders and is associated with structural and functional alterations affecting multiple organs and body systems. In addition to its metabolic consequences, hypothyroidism may influence the morphology of internal organs and the functional status of the musculoskeletal system. However, comprehensive hospital-based studies evaluating these manifestations simultaneously remain limited.
This observational hospital-based cross-sectional study will include adult patients with a previously established diagnosis of hypothyroidism who are receiving care at participating healthcare institutions. All participants will undergo standardized clinical examination, anthropometric assessment, ultrasonographic evaluation of internal organs, functional assessment of the musculoskeletal system, and laboratory testing according to the study protocol.
Ultrasonographic evaluation will include morphometric assessment of the liver, pancreas, and kidneys using standardized examination protocols. Anthropometric assessment will include body height, body weight, body mass index, waist circumference, hip circumference, calf circumference, arm span, and derived anthropometric indices. Functional assessment of the musculoskeletal system will include handgrip strength, the Five Times Sit-to-Stand Test, and other validated functional assessments specified in the protocol.
The primary outcomes are ultrasonographic morphometric changes of the liver, pancreas, and kidneys, together with morphofunctional impairment of the musculoskeletal system.
Secondary analyses will evaluate associations between these outcomes and demographic characteristics, duration of hypothyroidism, thyroid hormone status, anthropometric indices, physical activity, laboratory findings, and other clinical characteristics.
The findings are expected to improve understanding of systemic manifestations of hypothyroidism and contribute to the identification of practical and inexpensive markers for the early detection of organ involvement and musculoskeletal impairment in routine clinical practice.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdukhalim Kh. Abdurakhimov, PhD
- Phone Number: +998941010091
- Email: abduhalim@adti.uz
Study Locations
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Andijan, Uzbekistan, 170127
- Andijan State Medical Institute
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Contact:
- Abdukhalim Kh. Abdurakhimov, PhD
- Phone Number: +9988941010091
- Email: abduhalimaka@mail.ru
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 enrollment.
- Severe decompensated cardiovascular, hepatic, or renal disease preventing study procedures.
- Neurological or musculoskeletal disorders that preclude functional testing.
- Refusal or inability to provide informed consent.
- Incomplete clinical or laboratory data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients With Hypothyroidism
Adult patients with a previously established diagnosis of hypothyroidism who will undergo clinical examination, anthropometric assessment, ultrasonographic evaluation of the liver, pancreas and kidneys, functional assessment of the musculoskeletal system, and laboratory testing according to the study protocol.
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Participants will undergo a standardized diagnostic assessment including clinical evaluation, anthropometric measurements, ultrasonographic examination of the liver, pancreas, and kidneys, functional
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liver Longitudinal Diameter
Time Frame: Baseline
|
The longitudinal diameter of the liver will be measured by abdominal ultrasonography according to the standardized study protocol.
The measurement will be recorded in centimeters (cm).
|
Baseline
|
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Pancreatic Head Thickness
Time Frame: Baseline
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The anteroposterior thickness of the pancreatic head will be measured by abdominal ultrasonography according to the standardized study protocol.
The measurement will be recorded in millimeters (mm).
|
Baseline
|
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Kidney Length
Time Frame: Baseline
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The longitudinal length of each kidney will be measured by ultrasonography according to the standardized study protocol.
Measurements will be recorded in millimeters (mm).
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Baseline
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Handgrip Strength
Time Frame: Baseline
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Muscle strength will be assessed using a calibrated handgrip dynamometer.
Maximum grip strength will be recorded in kilograms (kg).
Higher values indicate greater muscle strength.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Five Times Sit-to-Stand Test
Time Frame: 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.
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Baseline
|
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Body Mass Index
Time Frame: Baseline
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Body mass index will be calculated as body weight divided by height squared and expressed in kilograms per square meter (kg/m²).
|
Baseline
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Waist Circumference
Time Frame: Baseline
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Waist circumference will be measured using a standardized anthropometric technique and recorded in centimeters (cm).
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Baseline
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Calf Circumference
Time Frame: Baseline
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Calf circumference will be measured at the point of maximum circumference and recorded in centimeters (cm).
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYPOMORPH-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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