Abstract
Background. Early intervention in prediabetes can prevent or delay the incidence of type 2 diabetes mellitus (T2DM). Traditional Chinese patent medicine (TCPM) is widely used in China to prevent T2DM. This study aims to evaluate the efficacy and safety of TCPMs for preventing T2DM. Method/Design. This study is a multicenter, cohort study with two arms. A total of 600 participants will be recruited. The participants will be divided into either intervention or control groups according to their own desire, and the exposure factor is the application of TCPMs. All participants will be encouraged to lead a healthy lifestyle, and the intervention group also used TCPMs based on syndrome differentiation. Incident diabetes and normalization of blood glucose are indexes of end point. Safety assessments and adverse event monitoring will also be conducted. The treatment duration is set for 24 weeks, and we will follow-up for another 2 years. Discussion. This trial may provide initial evidence regarding the efficacy and safety of TCPMs plus lifestyle intervention (LI) compared to LI alone for preventing T2DM and provide a comprehensive intervention plans that choose suitable TCPMs for diabetes prevention according to syndrome differentiation. Trial Registration Number. Chinese Clinical Trial Registry ID: ChiCTR1900023541, registered on 1 Jun 2019. The version identifier is 2018121702.
Highlights
Intervention in prediabetes can prevent or delay the incidence of type 2 diabetes mellitus (T2DM)
Several large-scale trials have demonstrated that use of some hypoglycemic drugs can decrease the incidence of diabetes to various degrees in those with prediabetes [12,13,14,15], though none are approved by the U.S Food and Drug Administration, for diabetes prevention. e cost, adverse reactions, tolerance, and other factors are needed to be considered [4, 16]
TCM may hold a promise in the prevention of T2DM because of its characteristics of “treat disease before it arises,” which include strengthening the body constitution and regulating the high-risk factors leading to diabetes; in addition, TCM could control the development of T2DM. is cognition corresponds with the thought of the prevention of T2DM
Summary
Intervention in prediabetes can prevent or delay the incidence of type 2 diabetes mellitus (T2DM). Traditional Chinese patent medicine (TCPM) is widely used in China to prevent T2DM. Is study aims to evaluate the efficacy and safety of TCPMs for preventing T2DM. Is trial may provide initial evidence regarding the efficacy and safety of TCPMs plus lifestyle intervention (LI) compared to LI alone for preventing T2DM and provide a comprehensive intervention plans that choose suitable TCPMs for diabetes prevention according to syndrome differentiation. People with IGT show normal fasting plasma glucose values (FBG less than 7.0 mmol/L) and abnormal two-hour postprandial blood glucose values (2h PG 7.8 to 11.0 mmol/L). Guidelines for the prevention and control of T2DM in China recommend that lifestyle interventions and weight loss can prevent prediabetes progress to T2DM [4]. Prediabetic individuals feel difficult to change their lifestyle, and the challenges posed in Evidence-Based Complementary and Alternative Medicine successful implementation and maintenance of certain lifestyle modifications. e pharmacological options recommended in the guidelines for prediabetes are limited
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