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DiabetEs Type 2 and thE Role of MacroalbumInuria; a diagnostic tool for vascular ageing with 18F-NaF PET/CT imaging

DiabetEs Type 2 and thE Role of MacroalbumInuria; a diagnostic tool for vascular ageing with 18F-NaF PET/CT imaging - DETERMINE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50619
Enrollment
50
Registered
2018-12-19
Start date
2019-01-09
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerose vascular stiffness

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria T2D patients: * Men and women, age above 18 years * Written informed consent * Using RAAS inhibitors * 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 ml/min/175m2 (CKD-EPI formula)

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 * 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 * Systolic blood pressure > 200 mmHg, 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 * 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 * Systolic blood pressure > 200 mmHg

Design outcomes

Primary

MeasureTime frame
Vascular 18F-NaF uptake (proxy for vascular macrocalcification) is quantified by using target-to-background ratios (TBRs).

Secondary

MeasureTime frame
* CT assessed arterial macrocalcification using measurement of hounds field units. * Albuminuria assessed in 2 separate 24-hours urine samples * Carotid-femoral PWV assessed arterial stiffness * C-reactive protein (CRP) assessed systemic inflammation * VAT volume assessed with CT * SAT volume assessed with CT * Body weight, length, BMI * Adipokines: adiponectin and leptin * Glycemic indices: HbA1c, insulin, HOMA-IR, fasting glucose * Lipid parameters: total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, apo-B, PCSK9 levels * Systolic and diastolic blood pressure * Kidney function and degree of albuminuria assessed using 24-hours urine creatinine clearance and albumin-to-creatinine ratio (ACR) * Plasma calcium phosphate metabolism plasma markers, including calcium, albumin, phosphate, vitamin D3, fetuin A, klotho, fibroblast growth factor 23, parathormone, serum calcification propensity score (T50).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)