Study of Canagliflozin to Reduce Vascular Inflammation in Adults with Diabetes and Stable Coronary Artery Disease

What this Trial Is About

Researchers are evaluating the effects of targeted anti-inflammatory therapy using canagliflozin on aortic inflammation in patients with diabetes and stable coronary artery disease CAD who are over 60 days post-myocardial infarction. This pilot study uses a randomized, double-blinded design to compare canagliflozin with a placebo over a 6-month treatment period. The primary goal is to measure changes in FDG aortic uptake, an imaging marker of inflammation, between baseline and 6 months. Participants will be randomly assigned to receive either a daily 300 mg oral dose of canagliflozin or a placebo for six months. The study is conducted in a single center and participants in both groups will have similar clinical evaluations and imaging assessments. Blood samples will be collected at baseline, 3 months, and 6 months to measure biomarkers and other laboratory tests. FDG PET imaging with contrast CT scans will be performed at baseline and after 6 months to evaluate aortic inflammation. During the study, participants will have clinical evaluations and blood tests, including measures of blood sugar control, inflammation, liver and kidney function, and blood counts at baseline and every 3 months. FDG PET imaging will be repeated at 6 months to assess changes in the aorta. The primary outcome is the change in tissue-to-blood ratio TBR of the most diseased segment of the ascending aorta. The total study duration for each participant is 6 months, and safety and inflammation markers will be monitored throughout.

Canagliflozin Targeting Vascular Inflammation