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Using ultrasound to measure muscle mass in people with metabolic diseases

Tests ultrasound for measuring muscle in adults with diabetes, obesity or metabolic syndrome.

Key facts

Who runs it
Zhangzhou Municipal Hospital
Where
Zhangzhou, ChinaSee the site
Trial code
Registry title
A Clinical Study on Using Multimodal Ultrasound to Assess Muscle Mass in Metabolic Diseases
Status
Recruiting
People taking part
320 people, planned
Started
1 Jul 2023
Expected to end
31 Dec 2027
Type of study
Observational, 4 groups
Record updated
23 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with metabolic syndrome, type 2 diabetes or simple obesity, and also healthy volunteers. It tests an ultrasound method to measure muscle mass.

Age
18 Years or older
Sex
All sexes can join.
Disease stage
Metabolic syndrome (at least 3 of 5 criteria: abdominal obesity, hypertension, hyperglycemia, hypertriglyceridemia, low HDL-C); or type 2 diabetes for at least 1 year; or simple obesity with BMI >= 28 kg/m² and no other metabolic problems; or healthy.
Earlier treatment
People cannot have used corticosteroids, muscle relaxants or other medicines that affect muscle metabolism for a long time.

Main reasons for not taking part

  • Severe liver or kidney failure, cancer, stroke, severe heart disease or autoimmune disease
  • Long-term use of corticosteroids, muscle relaxants or other medicines affecting muscle
  • Movement disorders, joint disease, muscle injury or muscular dystrophy
  • Pregnancy or breastfeeding
  • Cannot take part in the ultrasound, DXA scan or follow-up visits

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Long-term use of corticosteroids, muscle relaxants, or other medications affecting muscle metabolism
  • 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
  • Pregnancy or lactation
  • Inability to cooperate with ultrasound examination, DXA scanning, or follow-up assessments

Where in China

  • Zhangzhou Hospital, Fujian Medical UniversityZhangzhou, ChinaContact: Fahui Lu, Master'sTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Metabolic Syndrome Group

    Participants diagnosed with metabolic syndrome according to the Chinese Consensus on Diagnosis and Management of Metabolic Syndrome (2020 edition). Inclusion criteria: meeting at least 3 of the following 5 criteria: abdominal obesity, hypertension, hyperglycemia, hypertriglyceridemia, and low HDL-C.

  • Type 2 Diabetes Group

    Participants diagnosed with type 2 diabetes according to the ADA 2023 diagnostic criteria, with disease duration of at least 1 year.

  • Simple Obesity Group

    Participants with BMI ≥ 28 kg/m², without hypertension, hyperglycemia, dyslipidemia, or other metabolic abnormalities.

  • Healthy Control Group

    Healthy volunteers without metabolic diseases, muscle diseases, chronic liver/kidney diseases, malignancies, cardiovascular diseases, or neurological disorders. Age and sex matched to the other three groups.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Clinical Study on Using Multimodal Ultrasound to Assess Muscle Mass in Metabolic Diseases
Plain-language title
Using ultrasound to measure muscle mass in people with metabolic diseasesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 September 2026