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Diabetes type 2 and the role of macroalbuminuria; a diagnostic tool for vascular ageing with 18F-NaF PET/CT imaging.


- candidate number29612
- NTR NumberNTR7686
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-okt-2018
- Secondary IDs201800548 Research register UMCG
- Public TitleDiabetes type 2 and the role of macroalbuminuria; a diagnostic tool for vascular ageing with 18F-NaF PET/CT imaging.
- Scientific TitleDiabetes type 2 and the role of macroalbuminuria; a diagnostic tool for vascular ageing with 18F-NaF PET/CT imaging.
- ACRONYMDETERMINE study
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Accelerated vascular ageing, Diabetic nephropathy, Macroalbuminuria
- Inclusion criteriaInclusion 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 criteriaExclusion 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2018
- planned closingdate1-nov-2019
- Target number of participants50
- InterventionsNot applicable.
- Primary outcomeTo 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 outcome1. 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).
- TimepointsT0= informed consent
T1 = venapuncture, PWV measurement, 18F-NaF PET/CT scan
- Trial web siteNot applicable
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Reijrink
- CONTACT for SCIENTIFIC QUERIES M. Reijrink
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Siemens Germany
- PublicationsNone yet.
- Brief summaryType 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).
- Main changes (audit trail)
- RECORD1-okt-2018 - 2-jan-2019


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