Type 2 diabetes MedDRA version: 20.0 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent must be provided before participation • Previous participation in the ”Kardiovaskulær risikoprofil hos personer med og uden type 2 diabetes vurderet med hjerte 82Rb-PET - Projekt-ID H-3-2013-015” study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: • Pregnancy or breastfeeding (urine HCG is performed on all fertile women) • Myocardial infarction = 30 days before inclusion • Percutaneous coronary intervention = 4 weeks before inclusion • Coronary artery bypass graft = 8 weeks before inclusion • Heart transplantation • Unstable angina • Known severe heart failure (LVEF 200 mmHg • Chronic obstructive pulmonary disease or asthma, defined as requirement of daily medical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Primary end point(s): Degree of myocardial angiogenesis in persons with type 2 diabetes compared to non-diabetic controls;Timepoint(s) of evaluation of this end point: at only trial visit;Main Objective: To use 68Ga-NODAGA-E[c(RGDyK)]2 PET/CT scans as a tool to image myocardial angiogenesis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Association between degree of myocardial angiogenesis and albuminuria.;Timepoint(s) of evaluation of this end point: at only trial visit | — |
Countries
Denmark
Contacts
Public ContactDr Ripa
Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET
Outcome results
None listed