|- candidate number||6635|
|- NTR Number||NTR2062|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-okt-2009|
|- Secondary IDs||ABR-30390 CCMO|
|- Public Title||Consequences of suboptimal glucocorticoid replacement therapy in Addison’s disease; The metabolic syndrome and QoL.|
|- Scientific Title||Consequences of suboptimal glucocorticoid replacement therapy in Addison’s disease; The metabolic syndrome and QoL.|
|- hypothesis||1. Dutch patients with Addison's disease treated with suboptimal glucocorticoid replacement therapy have a reduced QoL; |
2. Prevalence of the metabolic syndrome is higher among patients with Addison's disease treated with suboptimal glucocorticoid replacement therapy compared to healthy controls.
|- Healt Condition(s) or Problem(s) studied||Metabolic syndrome, Addison's disease, Quality of life, Glucocorticoid receptor polymorfism|
|- Inclusion criteria||Patients with primary adrenal insufficiency in the age of 18-70 years.|
|- Exclusion criteria||1. Intercurrent infectious or serious disease; |
2. Use of other oral medications containing glucocorticoids;
3. High dose inhalation glucocorticoids (>800 microgram a day);
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-jan-2010|
|- planned closingdate||9-jan-2010|
|- Target number of participants||120|
|- Interventions||1. Questionnaires;|
2. Measurement of blood pressure, weight, height, waist circumference;
3. A fasting blood sample.
|- 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 in relation to the metabolic syndrome and QoL. |
|- Timepoints||Cross sectional.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| L.C.C.J. Smans|
|- CONTACT for SCIENTIFIC QUERIES|| L.C.C.J. Smans|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU)|
|- Brief summary||Introduction:|
Patients with Addison’s disease are treated with glucocorticoid replacement therapy (GRT). In spite of replacement therapy, patients with Addison’s disease experience a lot of complaints. Glucocorticoids are essential for life but in excess they produce many unwanted effects on metabolism, cardiovascular, musculoskeletal and immune function. Glucocorticoid side effects are probably dose dependent. The serious adverse effects of high dose GRT are reported in large trials in patients with different diseases including, asthma, SLE and rheumatoid arthritis. The evidence on which to support clear recommendations about toxicity of low dose glucocorticoids is weak. Patients with Addison’s disease are treated with long term low dose GRT. The effects of low dose GRT on quality of life and metabolism in this patient group are not clear.
Assess the prevalence of the metabolic syndrome and quality of life in patients with Addison’s disease treated with low dose GRT.
Case-control observational study.
Patients with primary adrenal insufficiency on a stable replacement therapy with glucocorticoids will be included in this study and results will be compared to data of age and sex matched controls.
Quality of life and prevalence of the metabolic syndrome.
Inconvenience, risks and advantages:
Blood samples will be obtained and participants have to complete questionnaires. There is a small risk of infection or haematoma formation when obtaining the blood sample. An advantage of participating in this study is treatment of risk factors if the metabolic syndrome is diagnosed.
|- Main changes (audit trail)|
|- RECORD||22-okt-2009 - 31-okt-2009|