Coronary Artery Disease Progression in Patients With Prediabetes
Status:
Active, not recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
Summary
Prediabetes is a disorder of glucose metabolism that reflects the natural history of
progression from normoglycaemia to type 2 diabetes mellitus. Patients with prediabetes have
impaired glucose regulation caused by insulin resistance (IR). IR in patients undergoing
percutaneous coronary intervention (PCI) is associated with coronary artery remodeling and
coronary plaque vulnerability by intravascular ultrasound (IVUS) analysis. In stent
restenosis after bare metal and drug-eluting stent implantation more frequently is observed
in patients with high fasting-insulin levels and IR. Although IR has a significant role in
the progression of atherosclerosis in prediabetic patients, the importance of managing
prediabetes is often under-appreciated by clinicians. To date, no pharmacological treatment
has been officially approved for prediabetes. According to American Diabetes Association
recommendations, metformin is the only drug that could be considered in the treatment of
prediabetic patients with a high risk of developing diabetes. Metformin is a safe and
inexpensive glucose lowering drug that attenuates mortality and future cardiovascular events
in patients with type 2 diabetes as well as the progression of atherosclerosis in
non-diabetic animal models. This study was designed to analyze coronary plaque
characteristics by iMAP IVUS in patients with and without prediabetes undergoing PCI and to
evaluate the impact of metformin treatment on coronary plaque characteristics in prediabetic
patients at 24 month follow up.
The study hypothesis is that more pronounced coronary atherosclerosis progression as well as
in-stent neointimal hyperplasia will be observed in patients with prediabetes. Metformin
treatment attenuates the progression of atherosclerosis in patients with prediabetes.