Background: Diabetes often accompanies with increase in triglyceride(TG) as well as small dense low density lipoprotein(sdLDL). Statins are difficult to completely correct this dyslipidemia. Xuezhikang, an extract of cholestin, is better than some statins in reducing TG. Under the condition of the similar decrease in LDL-cholesterol (LDL-C), it is not clear whether there is any difference in the effect of XZK and statins on TG reduction in patients with Type 2 DM(T2DM).
Methods: An open-label multicenter study is planned to estimate the effects of Xuezhikang(1.2 g/d) and pravastatin(20 mg/d) on TG level and other blood lipids in T2DM patients with dyslipidemia and moderate to high risk of cardiovascular diseases. A total of 114 patients will be enrolled and randomly assigned (1:1 ratio) to accept Xuezhikang or pravastatin therapy for 6 weeks. The primary outcome measure is the change in fasting TG level after 6 weeks. The changes in other fasting lipids and postprandial lipids at 1, 2, 4 h after a nutritious breakfast will also be explored. The planned duration for enrollment is between November 2021 and December 2022.
Conclusion: This study will evaluate the effect of 6-week treatment of Xuezhikang(1.2 g/d) and pravastatin(20 mg/d) on fasting TG level and other blood lipids in T2DM patients with dyslipidemia, which may provide a more optimized schedule for lipid control in patients with diabetes and dyslipidemia in primary prevention.