Research with human participants

Overview of medical research in the Netherlands

Metabolic adverse events and comorbidity in chronic rheumatoid arthritis patients.

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Last updated:

Rheumatoid 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;…

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Ethical review
Positive opinion
Status
Recruiting
Health condition type
-
Study type
Observational non invasive

ID

NL-OMON20413

Source

Nationaal Trial Register

Brief title

N/A

Health condition

rheumatoid artritis cardiovascular diseases glucose intolerance insuline resistance ischemic heart disease heart failure

Sponsors and support

Primary sponsor :
Top Institute Pharma
Source(s) of monetary or material Support :
Top Institute Pharma

Intervention

Outcome measures

Primary outcome

Influence 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 outcome

Effects of certain medication (glucocorticoids) on these parameters.

Background summary

N/A

Study objective

Rheumatoid 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).

Study design

One time point (cross-sectional).

Intervention

No intervention. 
Research protocol includes history, physical examination, oral glucose tolerance test, X-rays of chest, thoracic and lumbar spine, hands and foots, and electrocardiography.

Public
University Medical Center Utrecht (UMCU) <br>
Rheumatology & Clinical immunology <br>
F02.127<br>
PO Box 85500

M.C. Goes, van der
Utrecht 3508 GA
The Netherlands
+31 (0)88 7551770 (or #3357)
m.c.vandergoes@umcutrecht.nl
Scientific
University Medical Center Utrecht (UMCU) <br>
Rheumatology & Clinical immunology <br>
F02.127<br>
PO Box 85500

M.C. Goes, van der
Utrecht 3508 GA
The Netherlands
+31 (0)88 7551770 (or #3357)
m.c.vandergoes@umcutrecht.nl

Inclusion criteria

Chronic rheumatoid arthritis (according to ACR criteria for rheumatoid arthritis; disease duration over 2 years).

Exclusion criteria

None

Design

Study type :
Observational non invasive
Intervention model
:
Other
Allocation :
Non controlled trial
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
300
Type :
Anticipated

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

ID: 32316
Bron: ToetsingOnline
Titel: Top Institute Pharma (TIP) - research UMCU-rheumatology:
*Metabolic adverse events/co-morbidity in chronic rheumatoid arthritis patients*

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL1494
NTR-old NTR1564
Other METC UMC Utrecht : nr. 07/216
CCMO NL21596.041.08
OMON NL-OMON32316

Summary results

N/A