NCT07836088Recruiting
A Clinical Study on Using Multimodal Ultrasound to Assess Muscle Mass in Metabolic Diseases
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
This study aims to evaluate the clinical value of multimodal ultrasound for assessing muscle mass in patients with metabolic diseases, including metabolic syndrome, type 2 diabetes, and simple obesity. Skeletal muscle is the largest metabolic organ in the human body and plays a critical role in glucose metabolism. Muscle mass reduction is common in patients with metabolic diseases and is associated with insulin resistance, poor disease control, and increased risk of complications. Currently available methods for muscle assessment, such as dual-energy X-ray absorptiometry (DXA), computed tomography (CT), and magnetic resonance imaging (MRI), have limitations including high cost, radiation exposure, or poor portability, making them unsuitable for routine bedside monitoring. Multimodal ultrasound combines B-mode imaging, shear-wave elastography, superb microvascular imaging, and artificial intelligence analysis to provide a comprehensive evaluation of muscle morphology, stiffness, microcirculation, and quality. This non-invasive, radiation-free, and portable technique may serve as an ideal tool for muscle assessment in clinical practice. This prospective observational study will enroll 320 participants divided into four groups: metabolic syndrome (n=80), type 2 diabetes (n=80), simple obesity (n=80), and healthy controls (n=80). All participants will undergo baseline assessments including clinical data collection, biochemical tests, muscle function tests (handgrip strength, gait speed, Short Physical Performance Battery \[SPPB\]), multimodal ultrasound examination (muscle thickness, cross-sectional area, echo intensity, shear wave velocity, Young's modulus, microvascular density), and DXA measurement as the reference standard. The three metabolic disease groups will be followed prospectively for 12 months with repeat assessments at 6 and 12 months. The primary objectives are to determine diagnostic thresholds of multimodal ultrasound parameters for detecting metabolic sarcopenia; to establish correlation between ultrasound parameters and metabolic indicators (blood glucose, glycated hemoglobin \[HbA1c\], homeostatic model assessment of insulin resistance \[HOMA-IR\], lipids); to develop a combined diagnostic model integrating ultrasound and clinical parameters; and to evaluate the predictive value of baseline ultrasound parameters for 12-month disease progression and complications. The findings will provide a non-invasive, convenient, and widely applicable tool for early screening, risk stratification, and therapeutic monitoring of muscle abnormalities in patients with metabolic diseases.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 320 (estimated)
- First submitted
- 14 Sept 2026
- Start date
- 1 Jul 2023
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Zhangzhou Municipal Hospital
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT07836088
What you commit to
- Study type: Observational
- Planned participants: 320
- From 1 Jul 2023 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long-term use of corticosteroids, muscle relaxants, or other medications affecting muscle metabolism.
Other illness
- Severe hepatic or renal failure, malignancy, stroke, severe cardiovascular disease, or autoimmune diseases.
- Presence of movement disorders, joint diseases, muscle injury, muscular dystrophy, or other conditions affecting muscle function.
- Any other condition that, in the opinion of the investigator, would interfere with the study objectives or participant safety.
Other
- Pregnancy or lactation.
- Inability to cooperate with ultrasound examination, DXA scanning, or follow-up assessments.
Who the study is looking for
- Diagnosis of metabolic syndrome according to the Chinese Consensus on Diagnosis and Management of Metabolic Syndrome (2020 edition), meeting at least 3 of the following 5 criteria: abdominal obesity, hypertension, hyperglycemia, hypertriglyceridemia, and low HDL-C.
- Diagnosis of type 2 diabetes according to the ADA 2023 diagnostic criteria, with disease duration of at least 1 year.
- Body mass index (BMI) \>= 28 kg/m², without hypertension, hyperglycemia, dyslipidemia, or other metabolic abnormalities.
- Healthy volunteers without metabolic diseases, muscle diseases, chronic liver or kidney dysfunction, malignancies, cardiovascular diseases, or neurological disorders, and without long-term use of corticosteroids or other medications affecting muscle metabolism.
- Age and sex matched across all four groups.
- Willing and able to provide written informed consent and comply with all study procedures including ultrasound examination, DXA scan, and follow-up visits.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhangzhou Hospital, Fujian Medical University Coordinator of this site? Confirm its status | Zhangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.