Top Institute Pharma (TIP)-glucocorticoids research University Medical Centre Utrect (UMCU) rheumatology: cardiovascular risk factors and insulin resistancy in rheumatoid arthritis patients with and without glucocorticoids

ISRCTN ISRCTN53261020
DOI https://doi.org/10.1186/ISRCTN53261020
Secondary identifying numbers NTR1028
Submission date
23/08/2007
Registration date
23/08/2007
Last edited
17/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jos N. Hoes
Scientific

University Medical Centre Utrecht
Department of Rheumatology and Clinical Immunology, F02.127
Utrecht
3584 RD
Netherlands

Phone +31 (0)30 250 5240
Email mail@hoesjn.org

Study information

Study designObservational clinical trial
Primary study designObservational
Secondary study designSingle-centre
Study setting(s)Hospital
Study typeDiagnostic
Scientific title
Study acronymTIP-GC-UMCU
Study objectivesWhat is the relation between disease activity, treatment, and metabolic syndrome/insulin resistance?
Ethics approval(s)Ethics approval pending from the METC UMC-Utrecht (The Netherlands) as of 31st August 2007.
Health condition(s) or problem(s) studiedInsulin resistancy in rheumatoid arthritis patients
Intervention1. Oral glucose tolerance test (OGTT)
2. X-rays of hand, feet, lungs and spinal cord
3. Electrocardiogram (ECG)
Intervention typeOther
Primary outcome measure1. Metabolic syndrome/insulin resistance
2. Disease (RA) activity

Timepoints will be measured during a one time visit of the patient (duration approximately four hours).
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/10/2007
Completion date01/10/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants300
Key inclusion criteriaDiagnosis rheumatoid arthritis with disease duration greater than two years
Key exclusion criteriaDoes not comply with the above inclusion criteria
Date of first enrolment01/10/2007
Date of final enrolment01/10/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Centre Utrecht
Utrecht
3584 RD
Netherlands

Sponsor information

University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre

Department of Rheumatology and Clinical Immunology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Website http://www.umcutrecht.nl/zorg/
ROR logo "ROR" https://ror.org/04pp8hn57

Funders

Funder type

Industry

Top Institute Pharma (TIPharma) (The Netherlands)
Private sector organisation / Other non-profit organizations
Alternative name(s)
TI Pharma
Location
Netherlands

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan