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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Device: Ultrasonography; Radiation: Dual-energy X-ray Absorptiometry

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Leeuwarden, Friesland, Netherlands, 8934 AD
      • Medical Center Leeuwarden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population will consist of patients, who have participated in the MUSCLE study and have received bariatric surgery at the CON / MCL.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1; The population will consist of patients, who have participated in the MUSCLE study and have received bariatric surgery at the CON / MCL. A potential subject who meets any of the following criteria will be excluded from participation in this study: Inability to communicate in either Dutch or English; Weight over 204 kilograms (due to limitations of the DXA); Pregnancy; Pacemaker

Device: Ultrasonography; 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; Radiation: Dual-energy X-ray Absorptiometry; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lean mass measured by dual-energy X-ray absorptiometry	gold standard	1 time, 1 year after surgery
lean mass measured by ultrasound	using LLM7 and LLM3 formulas	1 time, 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight loss after surgery	total weight loss and excess weight loss (after bariatric surgery)	1 time, 1 year after surgery
change in lean mass	after bariatric surgery	1 time, 1 year after surgery
comorbidity status	Number of patients with resolution, improvement, same/worsened of comorbidities	1 time, 1 year after surgery
blood parameters (e.g. CK, CRP, cystatin C, myoglobine)	Concentration of blood parameters (e.g. CK, CRP, cystatin C, myoglobine)	1 time, 1 year after surgery

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Investigators: Principal Investigator: Marloes Emous, PhD, Medical Centre Leeuwarden

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Muscle mass; Sonography
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: MCLeeuwarden

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No