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The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial

Overview of attention for article published in Trials, January 2017
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Title
The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial
Published in
Trials, January 2017
DOI 10.1186/s13063-016-1762-x
Pubmed ID
Authors

Talia Palacios, Luis Vitetta, Samantha Coulson, Claire D. Madigan, Gareth S. Denyer, Ian D. Caterson

Abstract

Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases. An evidence-based multi-species probiotic was developed to encourage a shift in the gastrointestinal bacterial cohort from a disease-prone to a balanced state with the aim of improving metabolic markers associated with type 2 diabetes mellitus. Sixty adults with a body mass index ≥25 kg/m(2) with prediabetes or type 2 diabetes mellitus (diagnosed within the previous 12 months) will be enrolled in a double-blind, placebo-controlled pilot study. Participants will be randomized to a multi-species probiotic or placebo for 12 weeks. Both groups will receive lifestyle and nutritional advice. The primary outcome measure is the change between groups in fasting plasma glucose levels from baseline to 12 weeks. Secondary outcome measures include, but are not limited to, the change in lipid profile, systemic inflammation, gut permeability, and faecal microbial and metabolomic profiles. Blood and stool samples are collected at baseline and 12 weeks after treatment. Intentional manipulation of gastrointestinal microbial profiles may be useful for preventing and controlling type 2 diabetes mellitus and its associated metabolic complications. Australian New Zealand Clinical Trials Registry, ACTRN12613001378718 . Registered on 16 December 2013.

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Geographical breakdown

Country Count As %
Unknown 320 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 44 14%
Student > Master 41 13%
Researcher 30 9%
Student > Ph. D. Student 26 8%
Other 11 3%
Other 46 14%
Unknown 122 38%
Readers by discipline Count As %
Medicine and Dentistry 65 20%
Nursing and Health Professions 30 9%
Biochemistry, Genetics and Molecular Biology 15 5%
Agricultural and Biological Sciences 12 4%
Pharmacology, Toxicology and Pharmaceutical Science 12 4%
Other 46 14%
Unknown 140 44%