Abstract
BackgroundPre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes.Methods/DesignRandomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others.DiscussionThe aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes.Trial registrationChinese clinical trials register ChiCTR-TRC-00000401
Highlights
Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes
The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes
Another study confirmed that lifestyle interventions were not completely effective to prevent the development of type 2 diabetes for high-risk groups[3]
Summary
Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Some studies have discovered that about 5%-10% of pre-diabetes will develop into diabetes within one year and the occurrence of cardiovascular events in patients with pre-diabetes are higher than in healthy individual. Progress of pre-diabetes Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes; it can reduce micro-vascular and macro-vascular complications. Another study confirmed that lifestyle interventions were not completely effective to prevent the development of type 2 diabetes for high-risk groups[3]. The latest DREAM trial showed that the intervention of prediabetes can delay the disease process [8,9] These studies give us hope to prevent diabetes effectively
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