Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat) AND Change in % volume of noncalcified atherosclerotic plaque in the coronary arteries assessed by coronary CT versus routine management (intention-to-treat)

% change in volume of noncalcified atherosclerotic plaque assessed by coronary CT (as treated) between baseline and end of study

% change in volume of noncalcified atherosclerotic plaque assessed by coronary CT (intention to treat/as treated) between baseline and end of study

% change in volume of the entire atherosclerotic plaque assessed by coronary CT) (intention to treat/as treated) between baseline and end of study

% change in volume of individual components of atherosclerotic plaque assessed by coronary CT (intention to treat/as treated) between baseline and end of study

Conversion of non-calcified plaque to calcified plaque assessed by coronary CT (intention to treat/as treated) between baseline and end of study

Change in the number of high-risk atherosclerotic lesions defined as the presence of at least 2 high risk features among:

• Spotty calcifications
• Low attenuation plaques (low attenuation plaque, i.e. plaque density <30 HU)
• positive remodeling
• napkin ring sign assessed by coronary TK (intention-to-treat/as treated) between baseline and end of study

Change in the Pericoronary Fat Attenuation Index assessed by coronary TK (intention-to-treat/as treated) between baseline and end of study

Change in total body mass (expressed in kilograms) (intention-to-treat/as treated) between baseline and end of study

Change in body mass index (BMI), calculated as following body mass index (BMI) = total body mass / (height)^2 and expressed in kg/m2 (intention-to-treat/as treated) between baseline and end of study

Change in totabl body fat mass (expressed in kilograms) measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study

Change in Body Cell Mass (BCM) (expressed in kilograms) measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study

Change in fat to mass ratio (FMR), calculated as following fat to mass ratoi (FMR) = total body fat (TBF) / skeletal muscle mass measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study

Change in visceral fat area (expressed in cm2) measured by bioimpedance analysis (intention-to-treat/as treated) between baseline and end of study

Change in waist-to-hip index (WHI) measured by bioimpedance analysis between baseline and end of study

Change in concentration of high-sensitivity C-reactive protein between baseline and end of the study

Change in

• total cholesterol
• low-density lipoproteins (LDL)
• high-density lipoproteins (HDL)
• non-HDL cholesterol
• triglycerides
• lipoprotein A concentrations between baseline and end of the study

Change in the percentage of glycated hemoglobin (HbA1c) between baseline and end of study

Change in percentage of patients with normal blood pressure defined as systolic pressure <140 mmHg and diastolic pressure <90 mmHg between baseline and end of study

Change in the percentage of patients smoking tobacco (cigarettes, pipe, cigar, tobacco heating products) or electronic cigarettes as defined by the study protocol between baseline and end of study

Change in

• Percentage of patients classified in the "high" physical activity category;
• Percentage of patients classified in the "sufficient" physical activity category;
• Percentage of patients classified in the "insufficient" physical activity category between baseline and end of study

Change in the Dietary Approaches to Stop Hypertension (DASH) Index between baseline and end of study.

For each of the 8 DASH food groups, a score of 10 is assigned when the DASH recommendation is met, lower intakes are scored proportionately, and the 8 individual scores are summed to create the overall DASH adherence score, which could range from 0 to 80. The higher the score, the better the adherence.

Reference Günther AL, Liese AD, Bell RA, et al. Association between the dietary approaches to hypertension diet and hypertension in youth with diabetes mellitus. Hypertension. 2009 Jan;53(1):6-12

Number of patients diagnosed with of diabetes based on the criteria of the Polish Diabetes Association during the study

Number of patients hospitalized for heart failure during the study

Number of unscheduled hospitalizations during the study

Number of cardiovascular events and strokes (MACCE: death/myocardial infarction/revascularization/stroke) during the study

Change in Homeostatic Model Assessment - Insulin Resistance (HOMA-IR) between baseline and of study

Change in plasma concentration of catalase between baseline and end of study

Change in plasma concentration of superoxide dismutase (SOD) between baseline and end of study

Change in concentration of Oxygen Radical Absorbance Capacity (ORAC) between baseline and end of study

Change in concentration of total antioxidant capacity (TAC) between baseline and end of study