Ultrasound to Assess Sarcopenia in Prader Willi Syndrome

NCT06448871 | Completed DMC

• 1 other identifier: TCRD-TPE-112-28
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Prader-Willi Syndrome; Sarcopenia; Metabolic Syndrome

Keywords

Prader-Willi Syndrome; Sarcopenia; Ultrasound; skeletal muscle; body composition

Outcome Measures

Primary Outcomes (9)

• Muscle thickness ultrasound

  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.

  1 day

• Cross-sectional area ultrasound

  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.

  1 day

• Pennation angle ultrasound

  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.

  1 day

• DXA: total lean body mass

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

  1 day

• DXA: skeletal muscle (SM)

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

  1 day

• DXA: appendicular skeletal muscle mass index (ASMI)

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

  1 day

• DXA: fat mass index (FMI)

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

  1 day

• DXA: body fat mass (BFM)

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

  1 day

• DXA: percentage fat mass

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

  1 day

Secondary Outcomes (4)

• Handgrip and lateral pinch strength

  1 day

• Physical performance test: SPPB

  1 day

• Physical performance test: gait speed

  1 day

• Physical performance test: five-time chair stand test

  1 day

Study Arms (1)

group 1, pws group

Individuals with PWS, aged 7 to 65 years, and able to follow simple instructions in chinese language.

Diagnostic Test: Ultrasound assessment of the right lower extremity muscles; Diagnostic Test: Dual-energy X-ray absorptiometry (DXA) scan

Interventions

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.

group 1, pws group

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).

group 1, pws group

Eligibility Criteria

• Age: 7 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, 231, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

No biospecimen will be used in this study

MeSH Terms

Conditions

Prader-Willi Syndrome; Sarcopenia; Metabolic Syndrome

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Valeria Chiu, MD

  Taichung Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: June 7, 2024
• Study Start: October 17, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)