The hypothesis is that macroalbuminuria could be a proxy for early changes to the vascular wall in T2D patients and therefore could be an early clinical indication of accelerated vascular ageing. Therefore, there is a clinical need to early identify…
ID
Bron
Verkorte titel
Aandoening
Accelerated vascular ageing
Type 2 diabetes
Diabetic nephropathy/macroalbuminuria
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Type 2 diabetes mellitus (T2D) is associated with a strong increase in cardiovascular risk, which is a consequence of accelerated vascular ageing. This process is hallmarked by vascular remodeling, chronic low-grade inflammation, calcification, and increased vascular stiffness. Vascular ageing is more pronounced in T2D patients who are also suffering from chronic kidney disease (CKD). But, the direct causality and mechanisms underpinning relationships between kidney function and accelerated vascular ageing is still incomplete. Macroalbuminuria could be a proxy for early changes to the vascular wall in T2D patients and therefore could be an early clinical indication of accelerated vascular ageing. Therefore, there is a clinical need to early identify those patients at risk and to explore new pathways on which new interventions can be developed.
In particular T2D patients are accompanied with obesity, and whereas visceral adipose tissue (VAT) is playing a central role in causing insulin resistance and metabolic syndrome.
To study whether vascular calcification in T2D subjects with or without macroalbuminuria is more prominent, the whole body, and therefore vasculature, will be imaged with 18F-NaF PET. With this nuclear tracer, microcalcification and therefore vascular ageing, will be imaged.
non-invasively assessed as aortic pulse wave velocity (PWV) will be
performed. Also, venapuncture and a positron emission tomography (PET)/computed
tomography (CT) scan will be performed with nuclear tracer 18fluor-sodiumfloride (18F-NaF).
Doel van het onderzoek
The hypothesis is that macroalbuminuria could be a proxy for early changes to the vascular wall in T2D patients and therefore could be an early clinical indication of accelerated vascular ageing. Therefore, there is a clinical need to early identify those patients at risk and to explore new pathways on which new interventions can be developed.
Onderzoeksopzet
T0= informed consent
T1 = venapuncture, PWV measurement, 18F-NaF PET/CT scan
Onderzoeksproduct en/of interventie
Not applicable.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7444 |
| NTR-old | NTR7686 |
| Ander register | Research register UMCG : 201800548 |