Department of Endocrinology, Guang'anmen Hospital of China Academy of Chinese Medical Science, Beijing, China.
Department of Cardiovascularology, Key Laboratory of State Administration of TCM (Cardio-Cerebral Vessel Collateral Disease), Shijiazhuang, China.
Front Endocrinol (Lausanne). 2020 Jun 25;11:415. doi: 10.3389/fendo.2020.00415. eCollection 2020.
Metabolic syndrome (MS) is a powerful risk factor for cardiovascular and cerebrovascular diseases. Although lifestyle intervention reduces several of the symptoms of the syndrome and cardiovascular risks, the lifestyle intervention that yields the benefits is restrictive. Jinlida is a Chinese patent medicine that has shown activity in type 2 diabetes, which has been approved in China. Preclinical studies in Jinlida granules support an improved role of abnormal glucose and lipids metabolism as well as reducing weight. Here, we describe the protocol of an ongoing clinical trial investigating a new therapy for metabolic syndrome in patients with abnormal glucose metabolism. This study will enroll 880 subjects (aged 18-70 years) who have metabolic syndromes with abnormal glucose metabolism. All the participants in a double-blind, parallel, randomized, placebo-controlled trial, will receive Jinlida or placebo, orally, 9 g/time, three times daily for 2-4 years period on the basis of lifestyle intervention. The primary outcome measure (Incidence of type 2 diabetes) will be assessed during intervention cycles. Adverse events were monitored. All statistical tests will be performed using a two-sided test, and a ≤ 0.05 (two-sided test) will be considered to be statistically significant results. Results from this study will provide evidence on whether incorporating oral Jinlida granules treatment into lifestyle intervention can delay or inhibit the development of diabetes mellitus in metabolic syndrome subjects with abnormal glucose metabolism. Registered at http://www.chictr.org.cn/enIndex.aspx. Trial registration number: ChiCTR1900023241.
代谢综合征（MS）是心血管和脑血管疾病的强有力危险因素。虽然生活方式干预可降低该综合征的几种症状和心血管风险，但产生益处的生活方式干预是有限制的。津力达是一种中国专利药物，已在中国被批准用于 2 型糖尿病。津力达颗粒的临床前研究支持改善异常葡萄糖和脂质代谢以及减轻体重的作用。在这里，我们描述了一项正在进行的临床试验的方案，该试验研究了一种针对代谢综合征患者葡萄糖代谢异常的新疗法。 这项研究将招募 880 名（年龄 18-70 岁）患有葡萄糖代谢异常的代谢综合征患者。所有参与者均将接受津力达或安慰剂，口服，9 克/次，每日 3 次，2-4 年，在此基础上进行生活方式干预。主要观察指标（2 型糖尿病的发生率）将在干预周期中进行评估。监测不良事件。所有统计检验均采用双侧检验，≤0.05（双侧检验）将被认为是具有统计学意义的结果。 这项研究的结果将提供证据，证明将口服津力达颗粒治疗纳入生活方式干预是否可以延缓或抑制葡萄糖代谢异常的代谢综合征患者发生糖尿病。 在 http://www.chictr.org.cn/enIndex.aspx 注册。试验注册号：ChiCTR1900023241。
