Ultrasound to Assess Sarcopenia in Prader Willi Syndrome

Metabolic Syndrome Clinical Trial

— PWS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06448871
• Other study ID #: TCRD-TPE-112-28
• Status: Recruiting
• Start date: October 17, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
• Contact: Valeria Chiu, MD
• Phone: 0982766578
• Email: haydenbell28[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 65 Years

Eligibility

Inclusion Criteria:

• Genetically diagnosed individuals with PWS who can cooperate with the examinations AND
• Age-matched control individuals with normal BMI.

Exclusion Criteria:

• Individuals with PWS or age-matched control individuals with arthritis, fracture, or severe musculoskeletal deformities that would interfere with the examinations.
• Individuals with severe cognitive impairment who cannot read or sign the written consent.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Prader-Willi Syndrome
• Sarcopenia
• Syndrome

Intervention

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.
• 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).

Locations

Country	Name	City	State
Taiwan	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	DXA: total lean body mass	Lean index of total lean body mass (LBM) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA	1 day
Primary	DXA: skeletal muscle (SM)	Lean index of skeletal muscle (SM) with Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA	1 day
Primary	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
Primary	DXA: fat mass index (FMI)	Adipose index of fat mass index using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.	1 day
Primary	DXA: body fat mass (BFM)	Adipose index of body fat mass (BFM) using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.	1 day
Primary	DXA: percentage fat mass	Adipose index of percentage fat mass using Hologic QDR-4500A, Hologic, Inc., Waltham, MA, USA.	1 day
Secondary	Handgrip and lateral pinch strength	Grip strength and lateral pinch will be assessed bilaterally using an isometric Baseline hydraulic hand dynamometer and pinch gauge.	1 day
Secondary	Physical performance test: SPPB	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).	1 day
Secondary	Physical performance test: gait speed	In the gait speed test participants walk over a 4-meter distance at their normal pace.	1 day
Secondary	Physical performance test: five-time chair stand test	In the 5-time chair stand test participants perform five sit-to-stand movements as quickly as possible	1 day