Background: Type 2 diabetes Mellitus (T2DM) is characterised by a persistent low-grade inflammatory response associated with the development of insulin resistance . Variations in the type, diversity and metabolic capacity of gastrointestinal gastro-intestinal microbial communities have been shown to alter these metabolic and inflammatory pathways by shifting energy balance and storage and promoting metabolic endotoxaemia [2, 3].
Aim: The aim of this study is to assess the therapeutic effect of a novel probiotic on glucose metabolism in adults diagnosed with prediabetes and early T2DM.
Methods: Sixty adults with a BMI ≥25 kg/m2 and diagnosed with pre-diabetes or T2DM (within the previous 12 months) have been enrolled in a double-blind controlled clinical trial and randomised to a multi-strain probiotic or placebo for 12 weeks. Both groups received lifestyle advice. Measurements and samples are collected at baseline and 12 weeks after treatment. Outcome measures include fasting plasma glucose, 2-hour glucose tolerance, insulin, lipids, inflammatory markers, gut permeability, and faecal microbial and metabolomics profiles.
Results: Recruitment is complete and the study will be concluded in September 2016. The primary outcome of fasting blood glucose will be reported as well as secondary outcomes including insulin sensitivity, lipid profiles and inflammatory and permeability markers.
Discussion: Intentional manipulation of gastro-intestinal microbial profiles may be useful for regulating T2DM and its associated metabolic disorders.
Australian New Zealand Clinical Trials Registry: ACTRN12613001378718.
The authors gratefully acknowledge financial support for the present study from The University of Sydney and Medlab Clinical.
LV and SC participate in research on probiotics at Medlab Clinical. The authors CM, IC and TP declare that there are no conflicts of interest.