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 Di...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 DiabetesPrevention Study （REDUCES Study） reported that 1 years of therapy with Tianqi capsule reduced the risk of diabetes by32.1% compared with the placebo. Here we aimed to assess the long-term effect of Tianqi capsule on prevention ofT2DM in people with impaired glucose tolerance after discontinuation of active intervention. Methods/design： 420subjects will be followed-up for 8 years to assess the long-term effect of Tianqi capsule intervention. The causes of deathand the status of living subjects will be investigated. Follow-up data for living subjects will be collected by personalinterview and clinical examination and medical record review to determine diabetes status. Questionnaires will be givento all the subjects to investigate the factors that probably affect the diabetes status during the 8-year of discontinuation ofintervention. The primary outcome is the incidence of T2DM, and the secondary outcomes are body mass index, bloodglucose, blood lipids and blood pressure. The Cox proportional hazards model will be used to estimate the hazard ratiofor diabetes incidence. Analyses will be done with SAS 8.2 software package. Discussion： Results from this study mayprovide evidence for the long-term efficacy of Tianqi capsule in patients with prediabetes. The findings will provide abasis for further confirmatory studies. Ethics： The protocol has been approved by the Medical Ethics Committee ofGuang’anmen Hospital of China Academy of Chinese Medical Sciences （approval number 2016-046-KY-01）. Studyregistration number： ClinicalTrials.gov; NCT02848053.展开更多
文摘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 DiabetesPrevention Study （REDUCES Study） reported that 1 years of therapy with Tianqi capsule reduced the risk of diabetes by32.1% compared with the placebo. Here we aimed to assess the long-term effect of Tianqi capsule on prevention ofT2DM in people with impaired glucose tolerance after discontinuation of active intervention. Methods/design： 420subjects will be followed-up for 8 years to assess the long-term effect of Tianqi capsule intervention. The causes of deathand the status of living subjects will be investigated. Follow-up data for living subjects will be collected by personalinterview and clinical examination and medical record review to determine diabetes status. Questionnaires will be givento all the subjects to investigate the factors that probably affect the diabetes status during the 8-year of discontinuation ofintervention. The primary outcome is the incidence of T2DM, and the secondary outcomes are body mass index, bloodglucose, blood lipids and blood pressure. The Cox proportional hazards model will be used to estimate the hazard ratiofor diabetes incidence. Analyses will be done with SAS 8.2 software package. Discussion： Results from this study mayprovide evidence for the long-term efficacy of Tianqi capsule in patients with prediabetes. The findings will provide abasis for further confirmatory studies. Ethics： The protocol has been approved by the Medical Ethics Committee ofGuang’anmen Hospital of China Academy of Chinese Medical Sciences （approval number 2016-046-KY-01）. Studyregistration number： ClinicalTrials.gov; NCT02848053.
