Status:
COMPLETED
Activation Innate Immune System in Type 1 Diabetes
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
European Foundation for the Study of Diabetes
Conditions:
Diabetes Mellitus, Type 1
Cardiovascular Diseases
Eligibility:
All Genders
20-60 years
Brief Summary
Hyperglycemia is a well-known cardiovascular risk factor. It has also been shown that episodes of hyperglycemia increase the risk for cardiovascular diseases despite return to normoglycemia, a phenome...
Eligibility Criteria
Inclusion
- Group 1 and 2 (patients with type 1 diabetes):
- Diagnosis based on clinical criteria
- Duration of diabetes ≥10 years
- Age ≥20 years, ≤ 60 years
- Group 1: HbA1c \>64 mmol/mol
- Group 2: HbA1c ≤64 mmol/mol
- Written informed consent
- Group 3 (healthy controls):
- Absence of disease, no use of medication
- Matched for age, gender and BMI
- HbA1c \<42 mmol/mol
- Written informed consent
Exclusion
- Inability to provide informed consent
- Smoking
- Specific Medication use:
- Use of immunosuppressive drugs
- 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.)
- Use of acetylsalicylic acid
- Previous cardiovascular events (ischemic stroke/TIA (transient ischemic attack), 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
Key Trial Info
Start Date :
January 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 21 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03441919
Start Date
January 18 2018
End Date
January 21 2019
Last Update
April 2 2019
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre, Department of Internal Medicine
Nijmegen, Netherlands, PO BOX 9101, 6500 HB