Table_2_Basis and Design of a Randomized Clinical Trial to Evaluate the Effect of Jinlida Granules on Metabolic Syndrome in Patients With Abnormal Glucose Metabolism.docx

Background: 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.
Methods: 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 p ≤ 0.05 (two-sided test) will be considered to be statistically significant results.
Discussion: 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.
Clinical trial registration: Registered at http://www.chictr.org.cn/enIndex.aspx. Trial registration number: ChiCTR1900023241.

背景：代谢综合征（Metabolic syndrome, MS）是心脑血管疾病的强效风险因素。尽管生活方式干预可减轻该综合征的多种症状并降低心血管疾病风险，但此类干预手段往往具有较强的限制性。金利达（Jinlida）是一款已在中国获批的中国专利中成药，既往研究证实其对2型糖尿病（type 2 diabetes）具有干预活性。金利达颗粒的临床前研究表明，其可改善糖脂代谢异常状况并减轻体重。本研究将详述一项正在开展的临床试验方案，该试验针对合并糖代谢异常的代谢综合征患者，探索其新型治疗方案。
方法：本研究计划纳入880名年龄介于18至70岁的受试者，均为合并糖代谢异常的代谢综合征患者。本试验为双盲、平行设计、随机、安慰剂对照试验，所有受试者将在生活方式干预的基础上，口服金利达或安慰剂，每次9g，每日3次，干预周期为2至4年。本研究的主要结局指标为2型糖尿病发病率，将在各干预周期内进行评估。同时将对不良事件进行全程监测。所有统计检验均采用双侧检验，当双侧检验的p值≤0.05时，判定为具有统计学显著性差异。
讨论：本研究结果将为"在生活方式干预基础上联用口服金利达颗粒，能否延缓或抑制合并糖代谢异常的代谢综合征患者的糖尿病进展"这一问题提供循证医学依据。
临床试验注册：本试验已在http://www.chictr.org.cn/enIndex.aspx完成注册，试验注册号为ChiCTR1900023241。