Abstract
BackgroundAlterations in intestinal microbiota correlate with risk of development of obesity and type 2 diabetes. Probiotics have been suggested to play an important role in the management of dysglycemia, although the evidence is limited. In this study, we aim to explore the efficacy and safety of probiotics intervention in preventing type 2 diabetes in Chinese patients with impaired glucose tolerance.Methods/DesignA 24-month randomized intervention is conducted from January 2014 to December 2016. The target sample size for intervention is 200 middle-aged men and women aged 30–65 year-old with impaired glucose tolerance. Participants with persistent impaired glucose tolerance were assigned to group A (tablet A) and B (tablet B) in sequential order. The participants and investigators were blinded to the assignment. The primary outcome is development of diabetes. The secondary outcome measures include body composition, biochemical variables and the safety of the probiotics.DiscussionThe results from this trial will provide the evidence on the efficacy and safety of probiotics administration in preventing conversion of impaired glucose tolerance to diabetes in a Chinese context.Trial registrationChiCTRTRC13004024
Highlights
Alterations in intestinal microbiota correlate with risk of development of obesity and type 2 diabetes
The results from this trial will provide the evidence on the efficacy and safety of probiotics administration in preventing conversion of impaired glucose tolerance to diabetes in a Chinese context
impaired glucose tolerance (IGT) is associated with progressing to diabetes and risk of cardiovascular diseases
Summary
Alterations in intestinal microbiota correlate with risk of development of obesity and type 2 diabetes. Individuals with prediabetes, especially impaired glucose tolerance (IGT), are at higher risk of developing type 2 diabetes, compared with individuals with normal glucose tolerance. Studies have shown that early intervention in patients with IGT can significantly reduce the number of those patients who subsequently develop type 2 diabetes [2,3,4,5,6]. Those effective interventions conclude lifestyle modification and drug therapy. The efficacy of lifestyle modification in preventing the conversion of IGT to type 2 diabetes is proven [2, 3].
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