학술논문
Long-term effect of Chinese herbal medicine Tianqi Capsule on the incidence of diabetes:an 8-year cohort study protocol
Document Type
Academic Journal
Author
Source
传统医学研究（英文版） / Traditional Medicine Research. 3(4):166-172
Subject
Language
Chinese
ISSN
2413-3973
Abstract
背景:近年来,2型糖尿病(T2DM)发病率的快速升高已经成为对人类健康的巨大挑战,中医药可以为糖尿病的防治提供新的选择.天芪降糖胶囊糖尿病预防研究的研究结果显示:与安慰剂组相比,服用天芪降糖胶囊1年可使糖尿病发病率降低32.1%.方法/设计:本研究对最初参加天芪降糖胶囊糖尿病预防研究的420例受试者进行八年随访,观察该胶囊预防T2DM发生的远期疗效.调查随访者的生存状态,其中生存者通过电话随访、临床检查和医疗记录等多种方式确认其糖代谢状态.对受试者八年间的药物治疗情况以及饮食、运动等生活方式进行问卷调查,以观察是否有天芪降糖胶囊治疗作用以外的其他因素对受试者的糖代谢状态产生影响.主要研究结果为糖尿病发生率,次要研究结果为体重指数,血糖、血脂和血压指标.采用Cox生存分析模型估计糖尿病发生率的危险比.统计学处理均使用SAS 8.2统计软件完成.讨论:本研究数据将为评估天芪降糖胶囊预防T2DM发生的远期疗效提供依据,并为中药对糖耐量低减人群的早期干预提供依据.伦理:本方案已被中国中医科学院广安门医院医学伦理委员会批准(批准号:2016-046-KY-01).方案注册号:Clinical Trials.gov;NCT02848053.
Background: The rapid growth of type 2 diabetes mellitus (T2DM) remains a big challenge for clinicians worldwide. Traditional Chinese medicine may bring a new approach for solving this problem. The Tianqi Capsule Diabetes Prevention Study (REDUCES Study) reported that 1 years of therapy with Tianqi capsule reduced the risk of diabetes by 32.1% compared with the placebo. Here we aimed to assess the long-term effect of Tianqi capsule on prevention of T2DM in people with impaired glucose tolerance after discontinuation of active intervention. Methods/design: 420 subjects will be followed-up for 8 years to assess the long-term effect of Tianqi capsule intervention. The causes of death and the status of living subjects will be investigated. Follow-up data for living subjects will be collected by personal interview and clinical examination and medical record review to determine diabetes status. Questionnaires will be given to all the subjects to investigate the factors that probably affect the diabetes status during the 8-year of discontinuation of intervention. The primary outcome is the incidence of T2DM, and the secondary outcomes are body mass index, blood glucose, blood lipids and blood pressure. The Cox proportional hazards model will be used to estimate the hazard ratio for diabetes incidence. Analyses will be done with SAS 8.2 software package. Discussion:Results from this study may provide evidence for the long-term efficacy of Tianqi capsule in patients with prediabetes. The findings will provide a basis for further confirmatory studies. Ethics: The protocol has been approved by the Medical Ethics Committee of Guang'anmen Hospital of China Academy of Chinese Medical Sciences (approval number 2016-046-KY-01). Study registration number:ClinicalTrials.gov;NCT02848053.
Background: The rapid growth of type 2 diabetes mellitus (T2DM) remains a big challenge for clinicians worldwide. Traditional Chinese medicine may bring a new approach for solving this problem. The Tianqi Capsule Diabetes Prevention Study (REDUCES Study) reported that 1 years of therapy with Tianqi capsule reduced the risk of diabetes by 32.1% compared with the placebo. Here we aimed to assess the long-term effect of Tianqi capsule on prevention of T2DM in people with impaired glucose tolerance after discontinuation of active intervention. Methods/design: 420 subjects will be followed-up for 8 years to assess the long-term effect of Tianqi capsule intervention. The causes of death and the status of living subjects will be investigated. Follow-up data for living subjects will be collected by personal interview and clinical examination and medical record review to determine diabetes status. Questionnaires will be given to all the subjects to investigate the factors that probably affect the diabetes status during the 8-year of discontinuation of intervention. The primary outcome is the incidence of T2DM, and the secondary outcomes are body mass index, blood glucose, blood lipids and blood pressure. The Cox proportional hazards model will be used to estimate the hazard ratio for diabetes incidence. Analyses will be done with SAS 8.2 software package. Discussion:Results from this study may provide evidence for the long-term efficacy of Tianqi capsule in patients with prediabetes. The findings will provide a basis for further confirmatory studies. Ethics: The protocol has been approved by the Medical Ethics Committee of Guang'anmen Hospital of China Academy of Chinese Medical Sciences (approval number 2016-046-KY-01). Study registration number:ClinicalTrials.gov;NCT02848053.