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OpenTrials
Completed

NCT Number: NCT06448871

Ultrasound to Assess Sarcopenia in Prader Willi Syndrome

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.

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Key information

Conditions

Prader-Willi Syndrome Abnormalities, Multiple Atrophy Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glucose Metabolism Disorders Hyperinsulinism Imprinting Disorders Insulin Resistance Intellectual Disability Metabolic Diseases Metabolic Syndrome Muscular Atrophy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

7 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, 231, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound assessment of the right lower extremity muscles

Diagnostic Test

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.

Dual-energy X-ray absorptiometry (DXA) scan

Diagnostic Test

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).

Primary outcomes

  1. Muscle thickness ultrasound

    Time frame: 1 day

    Ultrasound scanning of the muscle thickness of rectus femoris (RF), vastus lateralis (VL), and gastrocnemius medialis (GM) using B-mode ultrasonography (LOGIQ S8, GE Healthcare, USA) and a 7-15 MHz linear array transducer.

  2. Cross-sectional area ultrasound

    Time frame: 1 day

    Ultrasound scanning of the cross sectional area of rectus femoris (RF) using B-mode ultrasonography (LOGIQ S8, GE Healthcare, USA) and a 7-15 MHz linear array transducer.

  3. Pennation angle ultrasound

    Time frame: 1 day

    Ultrasound scanning of the pennation angles of vastus lateralis (VL) and gastrocnemius medialis (GM) using B-mode ultrasonography (LOGIQ S8, GE Healthcare, USA) and a 7-15 MHz linear array transducer.

  4. DXA: total lean body mass

    Time frame: 1 day

    Lean index of total lean body mass (LBM) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA

  5. DXA: skeletal muscle (SM)

    Time frame: 1 day

    Lean index of skeletal muscle (SM) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA

  6. DXA: appendicular skeletal muscle mass index (ASMI)

    Time frame: 1 day

    Lean index of appendicular skeletal muscle mass index (ASMI) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA

  7. DXA: fat mass index (FMI)

    Time frame: 1 day

    Adipose index of fat mass index using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.

  8. DXA: body fat mass (BFM)

    Time frame: 1 day

    Adipose index of body fat mass (BFM) using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.

  9. DXA: percentage fat mass

    Time frame: 1 day

    Adipose index of percentage fat mass using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.

Secondary outcomes

  1. Handgrip and lateral pinch strength

    Time frame: 1 day

    Grip strength and lateral pinch will be assessed bilaterally using an isometric Baseline hydraulic hand dynamometer and pinch gauge.

  2. Physical performance test: SPPB

    Time frame: 1 day

    The short physical performance battery (SPPB) will be used, which measures balance, walking speed, strength, and endurance in the lower limbs, and is scored from zero to 12 (worst to best score).

  3. Physical performance test: gait speed

    Time frame: 1 day

    In the gait speed test participants walk over a 4-meter distance at their normal pace.

  4. Physical performance test: five-time chair stand test

    Time frame: 1 day

    In the 5-time chair stand test participants perform five sit-to-stand movements as quickly as possible

Sponsors and collaborators

Lead sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Other

Registry information

Official study title

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

Acronym: PWS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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