Clinical trial NCT06448871: Ultrasound to Assess Sarcopenia in Prader Willi Syndrome
Official title: Usefulness of Ultrasound to Assess Sarcopenia in Individuals With Prader Willi Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prader-Willi Syndrome
Sarcopenia
Metabolic Syndrome
Keywords: Prader-Willi Syndrome
Sarcopenia
Ultrasound
skeletal muscle
body composition
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 49
Sex: ALL
Minimum age (years): 7
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals with genetically confirmed PWS will be recruited from one of the Northern hospital outpatient center in Taiwan in the given time period.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Genetically diagnosed individuals with PWS who can cooperate with the examinations

Exclusion Criteria:

* Individuals with PWS who have arthritis, fractures, or severe musculoskeletal deformities that could interfere with the examinations.
* Individuals with PWS who have severe cognitive impairment and are unable to read or sign the written consent.

Primary outcomes:
measure: Muscle thickness ultrasound
timeFrame: 1 day
measure: Cross-sectional area ultrasound
timeFrame: 1 day
measure: Pennation angle ultrasound
timeFrame: 1 day
measure: DXA: total lean body mass
timeFrame: 1 day
measure: DXA: skeletal muscle (SM)
timeFrame: 1 day
measure: DXA: appendicular skeletal muscle mass index (ASMI)
timeFrame: 1 day
measure: DXA: fat mass index (FMI)
timeFrame: 1 day
measure: DXA: body fat mass (BFM)
timeFrame: 1 day
measure: DXA: percentage fat mass
timeFrame: 1 day
Secondary outcomes:
measure: Handgrip and lateral pinch strength
timeFrame: 1 day
measure: Physical performance test: SPPB
timeFrame: 1 day
measure: Physical performance test: gait speed
timeFrame: 1 day
measure: Physical performance test: five-time chair stand test
timeFrame: 1 day
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Valeria Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References: