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ID
Source
Brief title
Health condition
Obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
correlation between muscle mass measured by DEXA and one of the parameters.
Secondary outcome
the correlation between multiple parameters for muscle mass and muscle strength and the muscle mass measured by DEXA.
Background summary
Background: 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.
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 population: The population will consist of 120 people, either patients scheduled for a first intake at the Center Obesity Northern Netherlands (CON) or people invited through ads in local newspapers. All patients people between 18 and 65 years of age and a body mass index (BMI) above 40 kg/m2 or above 35 kg/m2 with obesity-related comorbidities are eligible to participate in this study.
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 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.
Study objective
Finding methods that are more accessible and cheaper, can be helpful in tracking changes in muscle mass during weight loss in these patients.
Study design
2
Inclusion criteria
- Between 18 and 65 years of age.
- BMI above 40 kg/m2 or above 35 kg/m2 with obesity-related comorbidities.
Exclusion criteria
- History of bariatric surgery
- Inability to perform physical tests e.g.:
o Conditions limiting them from physical test
o Inability to walk or stand
- 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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8086 |
| CCMO | NL71609.099.19 |
| OMON | NL-OMON54850 |