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Metabolic adverse events and comorbidity in chronic rheumatoid arthritis patients.


- candidate number4614
- NTR NumberNTR1564
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-dec-2008
- Secondary IDsnr. 07/216 METC UMC Utrecht
- Public TitleMetabolic adverse events and comorbidity in chronic rheumatoid arthritis patients.
- Scientific TitleMetabolic adverse events and comorbidity in chronic rheumatoid arthritis patients.
- ACRONYMN/A
- hypothesisRheumatoid arthritis patients have an increased risk on developing cardiovasculair disease compared to healthy controls. In this study we explore the influence of disease actitivity on certain cardiovascular parameters (glucose intolerance; lipids; ischemic heart disease).
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Rheumatoid arthritis, Heart failure, Glucose intolerance, Insulin resistance, Ischaemic heart disease
- Inclusion criteriaChronic rheumatoid arthritis (according to ACR criteria for rheumatoid arthritis; disease duration over 2 years).
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 28-jul-2008
- planned closingdate1-nov-2011
- Target number of participants300
- InterventionsNo intervention.
Research protocol includes history, physical examination, oral glucose tolerance test, X-rays of chest, thoracic and lumbar spine, hands and foots, and electrocardiography.
- Primary outcomeInfluence of disease-activity (by DAS and erosive joint damage) on metabolic parameters and comorbidities (insulin resistance, glucose intolerance, ischemic heart disease, heart failure, lipids).
- Secondary outcomeEffects of certain medication (glucocorticoids) on these parameters.
- TimepointsOne time point (cross-sectional).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. M.C. Goes, van der
- CONTACT for SCIENTIFIC QUERIESDrs. M.C. Goes, van der
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Rheumatology and Clinical Immunology
- Funding
(Source(s) of Monetary or Material Support)
Top Institute Pharma (TI Pharma)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-dec-2008 - 15-dec-2008


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