Accelerated vascular ageing Type 2 diabetes Diabetic nephropathy/macroalbuminuria
Conditions
Interventions
Not applicable.
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria T2D patients: • Men and women, age above 18 years • Written informed consent • eGFR above 60 • Fulfils ADA criteria for diabetes o Fasting plasma glucose ≥ 7.0 mmol/l OR o Random plasma glucose ≥ 11.1 mmol/l OR o HbA1C ≥ 6,5% Inclusion criteria healthy controls: • Men and women, age above 18 years • Written informed consent • eGFR above 60
Exclusion criteria
Exclusion criteria: Exclusion criteria T2D patients: • Type 1 diabetes • Clinically significant liver disease • Other causes for macroalbuminuria than nephropathy • Previous cardiovascular disease, defined as stable coronary artery disease or acute coronary syndrome, stroke or transient ischemic attack, peripheral artery disease • Known atrial fibrillation • Patients who are mentally incompetent and cannot sign a Patient Informed Consent • Claustrophobia • Pregnancy or breastfeeding women. • Current active bone malignancy or in the previous 6 months • Disorders affecting bone metabolism, e.g. hyperparathyroidism, Paget's disease • Using vitamin K antagonists • Using bisphosphonates, calcium or vitamin D Exclusion criteria healthy controls: • Type 1 or 2 diabetes • Micro- or macroalbuminuria • Clinically significant liver disease • Previous cardiovascular disease, defined as stable coronary artery disease or acute coronary syndrome, stroke or transient ischemic attack, peripheral artery disease • Known atrial fibrillation • Patients who are mentally incompetent and cannot sign a Patient Informed Consent • Claustrophobia • Pregnancy or breastfeeding women. • Current active bone malignancy or in the previous 6 months • Disorders affecting bone metabolism, e.g. hyperparathyroidism, Paget's disease • Using vitamin K antagonists • Using bisphosphonates, calcium or vitamin D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate whether arterial microcalcification (18F-NaF-PET detected) and macrocalcification (CT detected) are increased in patients with T2D with preserved renal function who have macroalbuminuria as compared to patients with normoalbuminuria. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To investigate whether arterial microcalcification (18F-NaF-PET detected) and macrocalcification (CT detected) are associated with vascular stiffness (assessed by PWV). 2. To investigate whether arterial microcalcification (18F-NaF-PET detected) and macrocalcification (CT detected) are associated with markers of the metabolic syndrome, including adipose tissue volumes (visceral and subcutaneous), adipokines, insulin resistance index (HOMA-IR), and clinical components (HbA1c, fasting glucose, lipid metabolism, and blood pressure). 3. To investigate whether arterial microcalcification (18F-NaF-PET detected) and macrocalcification (CT detected) are associated with markers of the calcium phosphate metabolism 4. To investigate which of the above mentioned factors (i.e. macroalbuminuria, metabolic syndrome, calcium phosphate metabolism, and kidney function) are independent determinants of arterial microcalcification (18F-NaF-PET detected) and macrocalcification (CT detected). | — |
Outcome results
None listed