Activation of the innate immune system and vascular inflammation in patients with type 1 diabetes mellitus
- Conditions
- Diabetes1001265310003216
- Registration Number
- NL-OMON44648
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Group 1: Type 1 diabetes, HbA1c > 64 mmol/mol; Group 2: Type 1 diabetes, HbA1c <64 mmol/l; Group 3: Healthy controls.
Group 1 and 2: type 1 diabetes, diagnosis based on clinical data, duration of diabetes *10 years, age *20 years, * 60 years, written informed consent
Group 3: absence of disease; matched for age,, gender and BMI; HbA1c <42 mmol/mol; written informed consent
- Inability to provide informed consent
- Smoking
- Specific Medication use:
o Use of immunosuppressive drugs
o Use of statins < 2 weeks before performing PET-CT (Those that use statins will be asked to discontinue for two weeks. This can be safely done in the context of primary prevention.)
o Use of acetylsalicylic acid
- Previous cardiovascular events (ischemic stroke/TIA, myocardial infarction, peripheral arterial disease)
- Auto-inflammatory or auto-immune diseases
- Current or recent infection (< 3 months)
- Previous vaccination (< 3 months)
- Renal failure (MDRD <45)
- BMI>30 kg/m2
- Pregnancy
- Claustrophobia
- Severe hypoglycaemia < 1 week before PET-CT
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Vascular wall inflammation in the aorta, left and right carotid artery and left<br /><br>and right iliac and femoral arteries, as quantified by FDG-PET scanning.</p><br>
- Secondary Outcome Measures
Name Time Method <p>FDG uptake in spleen and bone marrow.<br /><br>Ex vivo determination of the inflammatory/atherogenic phenotype, cellular<br /><br>metabolism of circulating monocytes and epigenetic signature of monocytes. </p><br>