Research with human participants

Overview of medical research in the Netherlands

Lipid changes after induction therapy in patients with Inflammatory Bowel Disease: effect of different drug classes and inflammation

No registrations found.

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

ID

NL-OMON22770

Source

NTR

Brief title

CIAT

Health condition

Inflammatory bowel disease

Sponsors and support

Primary sponsor :
Erasmus Medical Center (investigator-initiated)
Source(s) of monetary or material Support :
Not applicable

Intervention

Outcome measures

Primary outcome

Lipid changes after induction therapy (total cholesterol, HDL-c, LDL-c, triglycerides, apolipoprotein-B and lipoprotein a)

Secondary outcome

Association with drug class and inflammation

Background summary

Prospective, observational cohort study in patients with inflammatory bowel disease (IBD) assessing lipid changes after 10-week induction therapy with corticosteroids, thiopurines, methotrexate, anti-TNFα agents, vedolizumab, ustekinumab and tofacitinib

Study objective

Lipid changes are a more general consequence of improved systemic/intestinal inflammation

Study design

Baseline and week 10 (+- scope of 2 weeks)

Public
Erasmus Medical Center
Jasmijn Sleutjes

0627256693
j.sleutjes@erasmusmc.nl
Scientific
Erasmus Medical Center
Jasmijn Sleutjes

0627256693
j.sleutjes@erasmusmc.nl

Inclusion criteria

ii) IBD diagnosis, ii) age =>17 years, iii) starting systemic registered IBD drug therapy

Exclusion criteria

i) the use of lipid lowering drugs (with the exception of cholestyramine on stable dose throughout the study), ii) supplements containing plant sterols/stanols or cholestin, iii) pregnancy, iv) a history of liver transplantation

Design

Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Non-randomized controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
20
Type :
Actual

IPD sharing statement

Plan to share IPD :
Yes

Plan description

The data that supports the findings of this study are available in the (supplementary) material of this article. The IPD that support the findings of this study are available from the corresponding author upon reasonable request, including a research protocol. Data Transfer Agreement (DTA) needs to be drawn, checked by legals and signed by both parties. Only de-identified study data will be shared. Mechanism of data sharing will be in consultation with Erasmus MC's data protection officer.

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

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

No registrations found.

In other registers

Register ID
NTR-new NL9844
Other METC Erasmus MC : MEC-2019-0073