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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
The secondary parameters include: weight loss after surgery, lean mass change
after surgery and comorbidities (baseline vs. 1 year after surgery), results of
blood tests.
Other study parameters are some patient characteristics:
- Demographics: sex, age and ethnicity.
- Clinical data from the first year follow-up appointment: anthropometric
measures, medical history, underlying diseases, medication use, results of
blood tests, food-record and questionnaire.
Background summary
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.
Study 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 burden and risks
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.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
Participation in MUSCLE-study
Exclusion criteria
(1) Weight over 204 kg; (2) pregnancy; (3) pacemaker.
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83747.099.23 |