Assess the prevalence of the metabolic syndrome and quality of life in patients with Addison*s disease treated with low dose GRT. Study the relation between GRT, QoL and glucocorticoid receptor polymorphisms
ID
Source
Brief title
Condition
- Adrenal gland disorders
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Presence of metabolic syndrome (3 or more abnormalities of waist
circumference, blood pressure, triglycerides, HDL
cholesterol, glucose)
2) Quality of life score
Secondary outcome
Presence of glucocorticoid receptor polymorfisms and GRT in relation to the
metabolic syndrome and QoL.
Background summary
Patients with Addison*s disease are treated with glucocorticoid replacement
therapy (GRT). However, many patients still experience complaints. This is
probably due to our inability to exactly mimic the hypothalamic-pituitary
diurnal rhythm, frequently leading to under- or overtreatment. In excess,
glucocorticoids produce many unwanted effects on metabolism and the
cardiovascular system. The unwanted adverse effects of treatment with high dose
glucocorticoids are reported in large trials. Patients with Addison*s disease
are treated with long term low dose GRT. The evidence on which to support clear
recommendations about toxicity of low dose glucocorticoids is weak.
Difficulties in optimizing GRT could also be caused by glucocorticoid receptor
polymorphisms, because they lead to a variable response to glucocorticoids. The
effects of GRT and glucocorticoïd receptor polymorphisms on quality of life and
metabolism in patients with Addison*s disease are not clear.
Study objective
Assess the prevalence of the metabolic syndrome and quality of life in patients
with Addison*s disease treated with low dose GRT. Study the relation between
GRT, QoL and glucocorticoid receptor polymorphisms
Study design
Case-control observational study
Study burden and risks
Indexgroup:
Disadvantages of the study are the burden of height, weight, waist
circumference and blood pressure measurement, collection of blood and
completing the questionnaires concerning aspects of the replacement therapy and
quality of life. There is a small risk of infection or haematoma formation in
obtaining a blood sample.
An advantage of participating in this study is treatment of risk factors if the
metabolic syndrome is diagnosed.
Controlgroup:
Disadvantage of the study is the burden of completing questionnaires concerning
aspects of quality of life
elzenhof 17
2411 HM Bodegraven
Nederland
elzenhof 17
2411 HM Bodegraven
Nederland
Listed location countries
Age
Inclusion criteria
- primary adrenal insufficiency
- 18-70 years
- stable glucocorticoid replacement therapy (no adjustments of regime and dosage for 3 months)
Exclusion criteria
- intercurrent infectious or serious disease for which it is necessary to increase
glucocorticoid dosage
- high dose inhalation glucocorticoids (>800 microgram a day)
- pregnancy
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 |
|---|---|
| Other | 2062 (Nederlands trial register) |
| CCMO | NL30390.041.09 |