The role of gut microbiota and chronic inflammation as drivers of cardiovascular disease - Nijmegen Biomedical Study - Non Invasive markers of Atherosclerosis 3
- Conditions
- atherosclerosiscardiovascular disease100285931000796310003216
- Registration Number
- NL-OMON38378
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
- participant NIMA-NBS 2 study
- body mass index > 27 kg/m2
- Recent cardiovascular event (myocardial infarction, transient ischemic attack, stroke < 3 months)
- History of bariatric surgery or bowel resection
- Inflammatory bowel disease
- Coagulation defects
- Thrombocytopenia (thrombocytes < 100 x 10E9)
- Liver dysfunction (INR > 1.6)
- Renal dysfunction (estimated glomerular filtration rate < 30 ml/min/1.72m2)
- Use of oral or subcutaneous anti-coagulant therapy
- Use of thrombocyte aggregation inhibitors other than acetylsalicylic acid or carbasalate calcium
- Claustrofobia
- Metallic fragments, clips or devices in brain, eyes, spinal canal
- Implantable defibrillator or pacemaker (wires)
- Mandibular magnetic implants
- Neurostimulator, bladder stimulator, non-removable insulin pump
- Metal tissue-expander in chest
- Cochlear implant
- Ossicular replacement prosthesis
- Intolerance or allergy for lidocaine
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Descriptive data: Questionnaires<br /><br>DNA: Gene polymorphisms at DNA level<br /><br>Transcriptome: RNA expression in blood and adipose tissue<br /><br>Metabolome: Small molecule metabolites in blood en urine<br /><br>Microbiome: Presence of groups of bacteria<br /><br>Phenotype: Measures of atherosclerosis, adiposity, hepatic steatosis<br /><br>Functional data: Cytokine production by adipocytes, monocytes<br /><br>Follow-up data: Cardiovascular events registry</p><br>
- Secondary Outcome Measures
Name Time Method <p>-</p><br>