The efficacy and safety study of dietary supplement PURIAM110 on non-insulin taking Korean adults in the stage of pre-diabetes and diabetes mellitus: protocol for a randomized, double-blind, placebo-controlled, and multicenter trial-pilot study

The efficacy and safety study of PURIAM110 is a double-blinded, placebo-controlled, randomized, and multi-center clinical trial. A total of 45 subjects will participate in this study for 6 weeks.The present protocol will confirm the efficacy and safety of PURIAM110 for pre-diabetes, suggesting more basic knowledge to conduct further randomized controlled trials (RCT). In addition, PURIAM110 can be an alternative dietary supplemental remedy for diabetes patients.ISRCTN: ISRCTN44779824Pre-diabetes is a condition of potential diabetes mellitus with an increased risk of developing type 2 diabetes [1,2]. In other words, it is a state of either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). Pre-diabetes is asymptomatic in many occasions, but once it develops into type 2 diabetes, it makes patients suffer from polydipsia, polyuria, polyphasia, unusual weight loss, and extreme fatigue [3]. Unmanaged chronic diabetes mellitus affects quality of life and induces life-threatening diabetes-associated complications [4,5]. Its mortality rate cannot be ignored in Korea, becoming the fourth leading cause of death by 2030 [6]. According to the Korean National Health and Nutrition Survey (KNHNS) 2001, prevalence rates of diabetes were 1.4 million (8.1%) in Korean men and 1.3 million (7.5%) in Korean women. Nowadays, it is reported that about 308 million people worldwide are having impaired glucose tolerance (IGT) and among them 25% to 75% will develop diabetes [7,8]. Since the exact figures of Korean pre-diabetes patients and diabetes progressing rates were not reported [4], we can deduce from the above numerical statement that a considerable population must be at the status of potential diabetes. Socioeconomic expenditures are also high, at 193 million won per year for medication [4,9]. Therefore, preventing and treating efforts for the non-insulin taking patients in the stage of pre-diabetes and diabetes are urgently needed to lift the burden from both the nati