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 |
| Protocol serial number | NTR1028 |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | Top Institute Pharma (TIPharma) (The Netherlands) |
- 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
Scientific
University Medical Centre Utrecht
Department of Rheumatology and Clinical Immunology, F02.127
Utrecht
3584 RD
Netherlands
| Phone | +31 (0)30 250 5240 |
|---|---|
| mail@hoesjn.org |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational clinical trial |
| Secondary study design | Single-centre |
| Scientific title | |
| Study acronym | TIP-GC-UMCU |
| Study objectives | What 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) studied | Insulin resistancy in rheumatoid arthritis patients |
| Intervention | 1. Oral glucose tolerance test (OGTT) 2. X-rays of hand, feet, lungs and spinal cord 3. Electrocardiogram (ECG) |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Metabolic syndrome/insulin resistance |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 300 |
| Key inclusion criteria | Diagnosis rheumatoid arthritis with disease duration greater than two years |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3584 RD
Netherlands
3584 RD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
