Baseline characteristics of the study population in the Diabetes Atherosclerosis Intervention Study (DAIS)

The Diabetes Atherosclerosis Intervention Study (DAIS) is the first study designed a priori to determine whether correcting dyslipoproteinemia in type II diabetes will alter coronary atherosclerosis. It is a multinational randomized double-blind, placebo-controlled trial using micronized fenofibrate. Its primary end point is a change in the average mean segment diameter determined on coronary angiograms taken at the beginning and end of the treatment period. This study describes the population baseline characteristics. Four hundred eighteen individuals (305 men and 113 women) were randomized; 168 patients were from Canadian clinics and 250 from those in Europe. Because the patients in both regions were very similar, it was possible to pool their data. All had ≥1 minimally visible lesion on coronary angiography. Their average (±SD) lipid levels were: triglycerides 2.42 ± 1.00 mmol/L, total cholesterol 5.57 ± 0.70 mmol/L, low-density lipoprotein cholesterol 3.43 ± 0.70 mmol/L, and high-density lipoprotein cholesterol 1.03 ±0.20 mmol/L. They were in very good glycemic control (hemoglobin A1c [HbA1c] 7.51 ± 1.20%). The remainder of the coronary risk factors and demographic characteristics are described in the following. The characteristics of the DAIS population should determine whether correcting the dyslipoproteinemia seen in type II diabetes alters the progression and/or regression of angiographically determined coronary disease, to ascertain whether there is a difference between those with previous coronary intervention and those without, and to determine whether there is a gender effect.