Department of General Practice, The Second Affiliated Hospital of Dalian Medical University, Liaoning, China.
Medicine (Baltimore). 2021 Mar 26;100(12):e22272. doi: 10.1097/MD.0000000000022272.
Dyslipidemia is a main risk factor of cardiovascular disease in the diabetic patients. Niacin was found acutely to decrease the plasma concentration of free fatty acids by inhibiting their mobilization from adipose tissue. This present study is a double blinded, randomized, and prospective trial to determine the effect of niacin during dyslipidemia in type 2 diabetic patients.
This randomized controlled, double-blinded, single center trial is carried out according to the principles of Declaration of Helsinki. This present study was approved in institutional review committee of the Second Affiliated Hospital of Dalian Medical University. All the patients received the informed consent. Diabetic patients were randomized (1:1) to receive 3-month treatment with extended-release niacin or matching placebo. The major outcome of our present study was the change in the level of HbA1c from the baseline to week 12. Secondary outcome measures contained the levels of fasting blood glucose, the concentrations of serum transaminase, the other laboratory variables, and self-reported adverse events. The P < .05 was regarded as statistically significant.
We assumed that adding the niacin to the medication in patients with type 2 diabetes would reduce dyslipidemia and achieve target lipid levels.
This study protocol was registered in Research Registry (researchregistry5925).
脂代谢紊乱是糖尿病患者心血管疾病的主要危险因素。烟酸被发现可通过抑制脂肪组织中游离脂肪酸的动员而急性降低其血浆浓度。本研究是一项双盲、随机、前瞻性试验，旨在确定烟酸在 2 型糖尿病患者脂代谢紊乱中的作用。
本随机对照、双盲、单中心试验按照赫尔辛基宣言的原则进行。本研究得到了大连医科大学第二附属医院机构审查委员会的批准。所有患者均签署了知情同意书。糖尿病患者按 1:1 随机分为接受 3 个月缓释烟酸或匹配安慰剂治疗。本研究的主要终点为治疗 12 周时 HbA1c 水平与基线相比的变化。次要终点包括空腹血糖水平、血清转氨酶浓度、其他实验室变量和自我报告的不良事件。P<0.05 被认为具有统计学意义。
我们假设在 2 型糖尿病患者的药物治疗中添加烟酸可以降低脂代谢紊乱并达到目标血脂水平。
本研究方案在 Research Registry（researchregistry5925）注册。
