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Completed

NCT Number: NCT05732363

Evaluation of Different Methods to Measure Muscle Mass and Strength in a Population With Class II/III Obesity

Rationale: Weight loss therapies should aim to reduce fat mass while preserving both muscle mass and muscle strength. Consequently, there is a need for validated methods to measure muscle mass and strength. Current methods are either expensive and require trained technicians, or have not been validated in populations with class II/III obesity (BMI > 35 kg/m2). In our previous studies (MUST-MOP and MUSCLE study), we have validated the use of ultrasound (US) for the measurement of lean mass (a proxy for muscle mass) in a population with obesity. These studies showed that the use of US for the measurement of lean mass was feasible, reliable and valid. The aim of the current study is to validate the use of US for the measurement of lean mass after weight loss in a population of bariatric surgery patients.

Objective: Primary objective: To assess the validity of US to measure lean mass after weight loss in a population of bariatric surgery patients.

Secondary Objectives:

* To assess de differences in lean mass between DXA and US in this study compared to the MUSCLE-study. * To assess how the lean mass has changed after bariatric surgery and the effects of lean mass on total weight loss and resolution of comorbidities * To assess whether the change in lean mass has an effect on serum levels of markers for muscle mass.

Study design: This study is an observational follow-up study of the MUSCLE study and will take place in the Centre Obesity Northern-Netherlands (CON) at the Medical Centre Leeuwarden (MCL).

Study population: The population will consists of participants, who have participated in the MUSCLE study and have received bariatric surgery at the CON / MCL.

Main study parameters/endpoints: The main parameters of this study are: lean mass measured by DXA and US. The main endpoint of this study is the validity of the US measurement of lean mass compared to DXA.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no direct benefits for the participants. However, the results of this study can help to further validate the ultrasound as a cheaper and more accessible method to measure muscle mass. This can potentially be used in standard clinical care to assess muscle mass of patients during weight loss.

• The additional time investment: during first year follow-up appointment approximately 30 minutes.

The risks of most test are minor, even the small amount of radiation exposure, which means the risks and burden of this study outweigh the potentially obtainable knowledge.

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Key information

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participation MUSCLE study
  • ±1 year after bariatric surgery

Exclusion criteria

  • Inability to communicate in either Dutch or English
  • Weight over 204 kilograms (due to limitations of the DXA)
  • Pregnancy
  • Pacemaker

Treatment and study plan

Ultrasonography

Device

The US muscle measurement will be performed with the handheld portable Philips Lumify Sonography connected to a Samsung tablet. The measurement will take approximately 5-10 minutes. A seven-point measurement has to be performed based on the seven-site Jackson Pollock Generalized Prediction Equations for circumference and skinfold thickness measurements.6,7

Other names: ultrasound

Dual-energy X-ray absorptiometry

Radiation

The brand of the DXA scanner is the Hologic Discovery A, which has a weight limit of 204 kilograms. During the DXA scan, patients will be exposed to radiation, which is approximately 0.2 micro Sievert (µSv) for measuring body composition. For comparison: the average amount of background radiation per hour is approximately 0.23 µSv. The DXA body composition scan will be performed according to standard protocol by a specialized technician.

Primary outcomes

  1. lean mass measured by dual-energy X-ray absorptiometry

    Time frame: 1 time, 1 year after surgery

    gold standard

  2. lean mass measured by ultrasound

    Time frame: 1 time, 1 year after surgery

    using LLM7 and LLM3 formulas

Secondary outcomes

  1. weight loss after surgery

    Time frame: 1 time, 1 year after surgery

    total weight loss and excess weight loss (after bariatric surgery)

  2. change in lean mass

    Time frame: 1 time, 1 year after surgery

    after bariatric surgery

  3. comorbidity status

    Time frame: 1 time, 1 year after surgery

    Number of patients with resolution, improvement, same/worsened of comorbidities

  4. blood parameters (e.g. CK, CRP, cystatin C, myoglobine)

    Time frame: 1 time, 1 year after surgery

    Concentration of blood parameters (e.g. CK, CRP, cystatin C, myoglobine)

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Official study title

Evaluation of Different Methods to Measure Muscle Mass and Strength in a Population With Class II/III Obesity: A Follow-up Study

Acronym: MUSCLE-II

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 17, 2023
Registry last updated
May 9, 2025

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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