NCT06448871

Ultrasound to Assess Sarcopenia in Prader Willi Syndrome

Usefulness of Ultrasound to Assess Sarcopenia in Individuals With Prader Willi Syndrome

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Academic / Other
• Sex: All
• Age: 7 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to examine the clinical applicability of ultrasound as a diagnostic tool for sarcopenia in individuals with PWS by investigating the association between ultrasound-derived measurements, DXA-derived measurements, and sarcopenia-related outcomes.

Detailed description

Sarcopenia is an age-related loss of muscle mass plus low muscle strength, and/or low physical performance, that may affect over 25% of individuals over the age of 60, resulting in an increased likelihood of developing disability. Abnormal body composition with an increased in body fat mass and a decreased in skeletal muscle mass were noted in individuals with Prader Willi syndrome (PWS), thought to be related to hormonal deficiencies due to hypothalamic dysfunction, presenting as a unique congenital model of sarcopenia. Muscle mass can be measured by dual-energy X-ray absorptiometry (DXA) scan device, but it is expensive, increased radiation exposure, and not easily accessible in all clinical practice. Ultrasound (USD) is a non-invasive, without ionising radiation, low-cost, and easily accessible tool for the assessment of soft tissue. There were increasing evidence for the use of USD in the measurement of muscle thickness (MT), cross-sectional area (CSA) and pennate anle (PA) of different muscle groups in different populations. However, the use of USD as a routine diagnostic tool in individuals with PWS has not been reported yet. The aim of the study is to examine the clinical applicability of ultrasound as a diagnostic tool for sarcopenia in individuals with PWS by investigating the association between ultrasound-derived measurements, DXA-derived measurements, and sarcopenia-related outcomes.

Conditions

• Prader-Willi Syndrome
• Sarcopenia
• Metabolic Syndrome

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound assessment of the right lower extremity muscles	Rectus femoris cross sectional area (RFCSA), RF muscle thickness, vastus lateralis (VL) muscle thickness, Gastrocnemius medialis (GM) muscle thickness, VL pennation angle (PA), and GM PA.
DIAGNOSTIC_TEST	Dual-energy X-ray absorptiometry (DXA) scan	skeletal muscle mass (SM), appendicular skeletal muscle mass index (ASMI), total lean body mass (LBM), total fat mass (BF), percentage fat mass, and fat mass index (FMI).

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2024-06-07
• Last updated: 2024-10-09

Locations

1 site across 1 country: Taiwan