Evaluation of the feasibility and reproducibility of Muscle Sound® in a morbid obese population.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the feasibility of Muscle Sound® by using the percentage
of successful measurement at 7 different sites of the body.
Secondary outcome
Reliability (intra- and inter-observer variance)
Background summary
In obesity, muscle mass is estimated to be relatively low. A low muscle mass
together with high fat mass is also called sarcopenic obesity. Sarcopenic
obesity has been associated higher risks of diabetes mellitus type 2 and
hypertension, compared to general obesity. Sarcopenic obesity is also
characterized by lower psychological health, quality of life and all-cause
mortality compared to general obesity. This indicates that it is important to
preserve muscle mass during weight loss, which leads to a need for validated
methods for estimating muscle mass in obese populations. Recently new software
to quantify muscle with ultrasonography has been developed (Muscle Sound®).
This software has been validated in healthy adults, athletes and critically ill
patients. However, this software has yet to be validated in an obese
population.
Study objective
Evaluation of the feasibility and reproducibility of Muscle Sound® in a morbid
obese population.
Study design
This study is a prospective observational study to look at the feasibility and
reproducibility of ultrasonography to quantify muscle.
The patient will arrive at the MCL two hours prior to the bariatric surgery.
The first two measurement will be performed by two different researcher, while
the patient is waiting for the surgery. This is possible because the patient is
expected to be at the hospital ward 2 hours prior to surgery.
The third and final measurement will take place the day after bariatric
surgery. All patients receiving bariatric surgery will stay at the hospital
ward for at least 1 night, which makes it possible to measure them the day
after surgery.
The measurement itself will take approximately 5 minutes, and the patient will
be asked to stand during the measurement.
Study burden and risks
Both the risks and benefits of this study will be minimal for the subjects.
Sonography measures with sound waves, which do not cause damage to the
underlying tissues. In patients, it can cause slight discomfort as various body
parts will be measured.
Patients with known allergies for sonography gel are excluded from the study,
however unknown allergy for sonography gel can possibly cause an allergic skin
reaction. Skin reactions due to sonography gel are very rare (only mentioned in
case reports), and are mostly related to allergic contact dermatitis or contact
urticarial.
Sophialaan 1
Leeuwarden 8911AE
NL
Sophialaan 1
Leeuwarden 8911AE
NL
Listed location countries
Age
Inclusion criteria
All patients scheduled for bariatric surgery at the Center for Obesity
Netherlands (CON) are eligible to participate in this study.
Exclusion criteria
Allergy to one (or more) of the ingredients of the sonography gel
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69211.099.19 |
| OMON | NL-OMON24685 |