Condition category
Musculoskeletal Diseases
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
17/10/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jos N. Hoes

ORCID ID

Contact details

University Medical Centre Utrecht
Department of Rheumatology and Clinical Immunology
F02.127
Utrecht
3584 RD
Netherlands
+31 (0)30 250 5240
mail@hoesjn.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR1028

Study information

Scientific title

Acronym

TIP-GC-UMCU

Study hypothesis

What is the relation between disease activity, treatment, and metabolic syndrome/insulin resistance?

Ethics approval

Ethics approval pending from the METC UMC-Utrecht (The Netherlands) as of 31st August 2007.

Study design

Observational clinical trial

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

1. 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 measures

No secondary outcome measures

Overall trial start date

01/10/2007

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Diagnosis rheumatoid arthritis with disease duration greater than two years

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

300

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/10/2007

Recruitment end date

01/10/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht
Utrecht
3584 RD
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Industry

Funder name

Top Institute Pharma (TIPharma) (The Netherlands)

Alternative name(s)

TI Pharma

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes