Primary Objective: To assess which method for measuring muscle mass is most reliable compared to dual-energy X-ray absorptiometry (DEXA) scan in a population with class II/III obesity.Secondary Objectives:1. To assess which combination of methods…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main parameters: muscle mass measured by DEXA, ultrasound (US), bioelectrical
impedance analysis (BIA), anthropometric methods and 24-hour urine creatinine.
Main endpoint: correlation between muscle mass measured by DEXA and one of the
parameters.
Secondary outcome
Secondary parameters: muscle strength measured by handgrip strength;
biochemical measures; protein intake; and physical activity measured with
movement sensors and short questionnaire to assess health-enhancing physical
activity (SQUASH).
Secondary endpoint: the correlation between multiple parameters for muscle mass
and muscle strength and the muscle mass measured by DEXA.
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: 35-45 kg/m2). Therefore, the aim of
this study is to validate other methods or a combination of methods to measure
muscle mass in a population with class II/III obesity.
Study objective
Primary Objective: To assess which method for measuring muscle mass is most
reliable compared to dual-energy X-ray absorptiometry (DEXA) scan in a
population with class II/III obesity.
Secondary Objectives:
1. To assess which combination of methods for measuring muscle mass and muscle
strength is most reliable compared to the DEXA scan in a population with class
II/III obesity.
2. To assess the variance in muscle mass measured by DEXA in a population with
class II/III obesity.
3. To assess the influence of nutrition, exercise and hormones on muscle mass.
Study design
This study is a prospective cross-sectional study and will take place in the
Center Obesity Northern Netherlands (CON) at the Medical Center Leeuwarden
(MCL).
Study burden and risks
There are no direct benefits for the participants. However, the results of this
study may help to find a cheaper and more accessible method of measuring muscle
mass and strength in this population. This can be used to apply in standard
clinical care, to assess muscle mass of patients during weight loss.
The burden associated with this study includes:
- Additional time investment: During first intake approximately 1 to 1.5 hours
extra, at home there is an extra 5 minutes every time patients/volunteers need
to urinate (for urine-collection) and approximately 10 minutes to fill in the
SQUASH questionnaire.
- Physical activity: During the measurement of handgrip strength, the
patients/volunteers might move differently or more than they are used to, which
can result in minor muscle ache the days after measurement.
The risks of most test are minor, even the small amount of radiation exposure,
and we think that the potentially obtainable knowledge outweighs the risks and
burden of this study.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
- Between 18 and 65 years of age.
- BMI above 35 kg/m2
Exclusion criteria
- History of bariatric surgery
- Inability to perform physical tests
- Inability to communicate in either Dutch or English
- Weight over 204 kilograms (due to limitations of the DEXA)
- BMI above 50 kg/m2
- Pregnancy
- 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
In other registers
| Register | ID |
|---|---|
| CCMO | NL71609.099.19 |
| OMON | NL-OMON28423 |