K52 I10 E11 G35 I50 E88.9
Conditions
Interventions
Group 1: Patients with histologically confirmed Ulcerative colitis
Group 2: Patients with histologically confirmed Crohn's disease
Group 3: Patients with heart failure (according to ESC Guidelines 202
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Disease definition according to guidelines: - Ulcerative Colitis or Crohn's Disease, histologically confirmed - Heart Failure: ESC Guidelines 2021 - Metabolic Syndrome - Diabetes: Type 2 Diabetes Mellitus with or without insulin therapy - MS: Diagnosis according to McDonald 2017, Ref. Thompson et al. Lancet Neurol 2017 - Hypertension: Unger et al 2020 ‘2020 International Society of Hypertension Global Hypertension Practice Guidelines’ Hypertension. 2020;75:1334–1357
Exclusion criteria
Exclusion criteria: - Refusal to participate in the study - Lack of capacity to give consent - Pregnancy and/or active breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune/cytokine, metabolite, or proteomic signatures from mucosal interstitial fluids (IF), intestinal biopsies, and blood measured by mass spectrometry (CyTOF), CyTOF/imaging, or flow cytometry or ELISA or cytometric bead arrays or OLINK, respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| - Localization and quantification of bacteria by fluorescence in situ hybridization (FISH) - mRNA profiling by qPCR, single cell sequencing and spatial transcriptomics, respectively - Microbiome signatures using sequencing methods (NGS) of stool samples or biopsies (mucosa associated microbiota) - Collection of histological and endoscopic scores (available from routine care, not study-specific) - Clinical severity score (EDSS) in MS/NMOSD - Reduction of ejection fraction EF (%) and global longitudinal strain (GLS, %) measured by echocardiography - Enlargement of the left ventricle (left ventricular end-diastolic diameter LVEDD, cm), measured by echocardiography - Increase in intima-media thickness (mm), measured by echocardiography - Increase in heart rate (bmp) - Increase in creatinine (mg/dl), measured in spontaneous urine - Reduction in cardiopulmonary endurance, measured as walking distance in the 6-minute walk test (m) - Increase in skin autofluorescence (arbitrary units), measured by AGE reader - Reduction of hand grip strength (kg), measured by dynamometer - Increase in body fat percentage (%), measured by bioimpedance analysis - Increase in systolic and diastolic cBP (mmHg) in conjunction with increased PWV (m/s), measured with Mobil-O-Graph and PulsePen - Reduction of flow-mediated vasodilation (FMD, µm) of the brachial artery, measured with UNEX EF 38G - Reduction of reactive hyperemia index (RHI) measured by plethysmography on the index finger by EndoPat 2000 - Major fluctuations in blood glucose level during the day (mmol/l), measured by blood glucose sensor - Increase in choroidal thickness (µm) and retinal macular volume (RMV, mm³), measured by fundus camera and optical coherence tomography (OCT) - Slowed dilation capacity of retinal vessels in association with increased recovery time (s) upon stimulation with flicker light, measured with Dynamic Vessel Analyser (DVA) | — |
Countries
Germany
Contacts
Public ContactKristin Kräker
Experimental and Clinical Research Center
Outcome results
None listed