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

Completed

• Conditions: atherosclerose; vascular stiffness; 10012653; 10029149; 10003216

• Registration Number: NL-OMON50619
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

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 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Vascular 18F-NaF uptake (proxy for vascular macrocalcification) is quantified<br /><br>by using target-to-background ratios (TBRs). </p><br>