背景:糖尿病前期强烈增加2型糖尿病和心血管事件的风险。然而,生活方式干预,目前是糖尿病前期的一线治疗,对葡萄糖代谢不一致有益,和常规药物,比如二甲双胍,由于可能的副作用,对糖尿病前期有争议。
目的:本研究旨在评价振源胶囊的作用,一种中成药,由人参成熟浆果中提取的人参浆果皂苷组成,糖尿病前期患者的糖代谢作为补充治疗。
方法:在本随机分组中,双盲,安慰剂对照,交叉试验,195名糖尿病前期参与者以1:1的比例随机接受安慰剂,然后接受振源胶囊,反之亦然,生活方式干预。每个治疗期持续4周,其间有4周的清除期。主要结果是空腹血糖(FPG)和餐后2小时血糖(2小时PG)相对于基线的变化。次要结局包括空腹和餐后2小时胰岛素和C肽的变化,稳态模型评估-胰岛素抵抗(HOMA-IR)指数和定量胰岛素敏感性检查指数(QUICKI)。还评估了血脂和不良事件。
结果:与安慰剂相比,调整治疗顺序后,镇源胶囊使2-hPG(-0.98mmol/l)显着降低。振源胶囊还降低了空腹和餐后2小时的胰岛素和C肽水平,降低HOMA-IR指数(-1.26),与安慰剂相比,提高了QUICKI指数(+0.012)。此外,振源胶囊患者的高密度脂蛋白胆固醇(HDL-C;0.25mmol/l)显着增加。研究期间未发生严重不良事件。
结论:在糖尿病前期患者中,振源胶囊进一步降低2小时PG水平,在生活方式干预的背景下,减轻胰岛素抵抗并提高HDL-C水平。研究方案在中国临床试验注册中心(ChiCTR2000034000)注册。
BACKGROUND: Prediabetes strongly increases the risk of type 2 diabetes and cardiovascular events. However, lifestyle intervention, the first-line treatment for prediabetes currently, was inconsistently beneficial for glucose metabolism, and the conventional medicines, such as metformin, is controversial for prediabetes due to the possible side effects.
OBJECTIVE: This
study was designed to evaluate the effects of Zhenyuan Capsule, a Chinese patented medicine consisting of ginseng berry saponins extracted from the mature berry of Panax Ginseng, on the glucose metabolism of prediabetic patients as a complementary therapy.
METHODS: In this randomized, double-Blinded, placebo-controlled, crossover
trial, 195 participants with prediabetes were randomized 1:1 to receive either placebo followed by Zhenyuan Capsule, or vice versa, alongside lifestyle interventions. Each treatment period lasted 4 weeks with a 4-week washout period in between. The primary outcomes were the changes in fasting plasma glucose (FPG) and 2-h postprandial plasma glucose (2-h PG) from baseline. Secondary outcomes includes the changes in fasting and 2-h postprandial insulin and C-peptide, the homeostatic model assessment-insulin resistance (HOMA-IR) index and quantitative insulin sensitivity check index (QUICKI) from baseline. Blood lipids and adverse events were also assessed.
RESULTS: Compared with placebo, Zhenyuan Capsule caused remarkable reduction in 2-h PG (-0.98 mmol/l) after adjusting treatment order. Zhenyuan Capsule also reduced the fasting and 2-h postprandial levels of insulin and C-peptide, lowered HOMA-IR index (-1.26), and raised QUICKI index (+0.012) when compared to placebo. Additionally, a significant increase in high density lipoprotein cholesterol (HDL-C; +0.25 mmol/l) was found in patients with Zhenyuan Capsule. No serious adverse event occurred during the
study.
CONCLUSIONS: Among prediabetic patients, Zhenyuan Capsule further reduced 2-h PG level, alleviated insulin resistance and raised HDL-C level on the background of lifestyle interventions. The
study protocol is registered with the Chinese Clinical
Trial Registry (ChiCTR2000034000).