Clinical trial NCT05732363: Evaluation of Different Methods to Measure Muscle Mass and Strength in a Population With Class II/III Obesity
Official title: Evaluation of Different Methods to Measure Muscle Mass and Strength in a Population With Class II/III Obesity: A Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Keywords: Muscle mass
Sonography
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: lean mass measured by dual-energy X-ray absorptiometry
timeFrame: 1 time, 1 year after surgery
measure: lean mass measured by ultrasound
timeFrame: 1 time, 1 year after surgery
Secondary outcomes:
measure: weight loss after surgery
timeFrame: 1 time, 1 year after surgery
measure: change in lean mass
timeFrame: 1 time, 1 year after surgery
measure: comorbidity status
timeFrame: 1 time, 1 year after surgery
measure: blood parameters (e.g. CK, CRP, cystatin C, myoglobine)
timeFrame: 1 time, 1 year after surgery
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
state: Friesland
Study officials:
affiliation: Frisius Medisch Centrum
name: Marloes Emous, PhD
role: PRINCIPAL_INVESTIGATOR
References: