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

Obesity, Morbid Clinical Trial

— MUSCLE-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732363
• Other study ID #: MCLeeuwarden
• Status: Recruiting
• Start date: June 27, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Medical Centre Leeuwarden
• Contact: Dionne Sizoo, MSc
• Phone: 0582861968
• Email: dionne.sizoo[@]mcl.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

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

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.

Locations

Country	Name	City	State
Netherlands	Medical Center Leeuwarden	Leeuwarden	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lean mass measured by dual-energy X-ray absorptiometry	gold standard	1 time, 1 year after surgery
Primary	lean mass measured by ultrasound	using LLM7 and LLM3 formulas	1 time, 1 year after surgery
Secondary	weight loss after surgery	total weight loss and excess weight loss (after bariatric surgery)	1 time, 1 year after surgery
Secondary	change in lean mass	after bariatric surgery	1 time, 1 year after surgery
Secondary	comorbidity status	Number of patients with resolution, improvement, same/worsened of comorbidities	1 time, 1 year after surgery
Secondary	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