Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Ulcerative colitis, clinically in remission >18 years of age
Exclusion criteria
Exclusion criteria: Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial function as assessed by brachial artery flow mediated dilatation (FMD). Statistical analyses. Brachial Flow mediated dilatation (FMD, %) is the primary endpoint of the study. FMD*s of the UC group and controls will be compared. For normally distributed data an (un)paired Student*s t-test will be used. The Wilcoxon or Mann-Whitney U test will be used for non-normally distributed data. A p-value of | — |
Secondary
| Measure | Time frame |
|---|---|
| Carotid intima media thickness (CIMT) Blood pressure assessments: RR, Ankle-brachial index (ABI), pulse-pressure (PP) and the brachial-ankle pulse wave velocity (baPWV). Routine outpatient clinical investigations. Statistical analyses. CIMT*s and BP*s/ABI*s between the UC group and controls group will be compared using Student*s unpaired t-test. Multiple comparisons of the vascular endpoints between the UC treatment groups and controls will be assessed using ANOVA. Bonferroni*s correction will be applied if appropriate. Correlations among clinical index scores, biochemical parameters, ultrasonographic parameters will be analysed using a Pearson correlation coefficient or Spearman rho correlation coefficient when data is normally or not-normally distributed respectively. To evaluate intra-observer variability of the vascular assessments the mean absolute differences between initial and repeat assessments and kappa-statistics will be used. | — |
Countries
Netherlands
Outcome results
None listed