1) to investigate the occurrence and severity of muscle loss in patients with AS,2) to explore determinants of muscle loss,
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
muscle mass (body compostition), physical activity, physical fitness, markers
of inflammation and muscle metabolism
Secondary outcome
questionnaire assessed quality of life, disease activity, fatigue
Background summary
A healthy muscle mass is essential for daily life functioning. An accelerated
loss of muscle mass is observed in the elderly (sarcopenia) and in chronic
diseases such as chronic obstructive pulmonary disease (COPD) and rheumatoid
arthritis (RA). In these chronic diseases, muscle loss is associated with
reduced muscle strength, physical fitness, the ability to perform activities of
daily life and hence quality of life, and is an independent predictor of
mortality. Muscle loss can be caused by the pro-inflammatory cytokine tumour
necrosis factor, especially TNF-* and by reduced physical activity. Ankylosing
Spondylitis (AS) is a chronic inflammatory disorder of the spine and in a about
20% of patients of the peripheral joints, and causes functional limitations.
TNF-* plays an essential role in the pathophysiology of the disease. Likley,
these patients are at risk for muscle loss, which might contribute to their
physical impairment and reduced quality of life.
Study objective
1) to investigate the occurrence and severity of muscle loss in patients with
AS,
2) to explore determinants of muscle loss,
Study design
Patients with AS will be matched to age (5 years) and gender matched family
members, preferably a brother or sister.
Body composition, including muscle mass, will be assessed using underwater
weighing, deuterium dilution and magnetic resonance imaging (MRI). PA will be
monitored during daily life using an extensively validated tri-axial
accelerometer. Fitness will be assessed using an incremental bicycle test and
with a newly developed fitness index. Commonly used questionnaires for the
assessment of quality of life and disease activity will be included and blood
samples will be taken and analysed for TNF-*, C-reactive protein (CRP),
erythrocyte sedimentation rate (ESR), the presence of the HLA B27 antigen,
total cholesterol and triglycerides. A muscle biopsy will be taken (optional)
to investigate local effects of TNF-* on the muscle. Biopsies will be analysed
for muscle fibre type distribution and for molecular markers known to be
involved in muscle cell differentiation and apoptosis (NF-*B, MyoD, Caspase).
Study burden and risks
All techniques used for this study are non-invasive except for the blood sample
and muscle biopsy. The biopsy is optional. Subjects can choose to participate
without a muscle biopsy. The blood sample is part of standard medical treatment
for the patients, but not for controls. All other techniques are of a very low
risk and place little burden on the subject.
PB616
6200MD Maastricht
Nederland
PB616
6200MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Patients, between the age of 18 and 65, diagnosed with Ankylosing Spondylitis (AS) according to the New York Criteria for AS, with a BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) >4, eligible for anti-TNF therapy according to the national guidelines.
Healthy controls: same gender, age within 5 years (and between 18 and 65) and family member of the respective patient.
Exclusion criteria
Patients with other conditions known to affect energy metabolism (energy intake and/or expenditure) such as chronic inflammatory disorders (inflammatory bowel disease, COPD, rheumatoid arthritis,..), malignancies, AIDS, dieting will be excluded.
Controls will be excluded when any disorder known to affect energy metabolism is present (Ankylosing Spondylitis or any disorder listed above).
Subjects that meet any of the exclusion criteria for MRI (electronic implants, pacemakers, metal fragments in the eyes, skin or body) will be excluded.
Design
Recruitment
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 | NL17118.068.07 |