The investigators aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes patients by improving gut hormone secretion and compare these findings to healthy lean subjects.
Prediabetes and diabetes are accompanied by insufficient gut hormone release, insulin resistance, insufficient insulin secretory capacity and low grade systemic inflammation. Results of recent animal experiments suggest that ingestion of probiotics not only influences gut microbiota composition and intestinal permeability but also secretion of GLP-2 as well as insulin resistance, components of metabolic syndrome and diabetes development. GLP-2 secretion has been suggested to be a key mediator of probiotic effects mediating decreased intestine permeability through binding to intestinal GLP2 receptor in animal studies. Insulinotropic GLP-1, which is reduced in patients with type 2 diabetes, has also been described to be influenced by gut microbiota composition. We aim to test the hypothesis that Lactobacillus Reuteri-enriched microbiota improves insulin sensitivity and glucose tolerance in obese healthy and obese type 2 diabetes patients by improving gut hormone secretion. In a prospective, double-blinded, placebo controlled randomized 10 weeks trial we aim to investigate metabolic and immunological changes related to modified gut microbiota by analysing (1) gut hormone secretion, (2) insulin sensitivity and glucose tolerance, and (3) systemic LPS concentrations and immune status.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
20
twice daily
German Diabetes Center
Düsseldorf, Duesseldorf, Germany
RECRUITINGInsulin resistance
Time frame: 8 weeks
gut hormones (GLP-1, GLP-2, GIP)
Time frame: 8 and 10 weeks
insulin secretion
Time frame: 8 and 10 weeks
measurement of cytokines to define the immune status
measurement and analysis of proinflammatory cytokines (Interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-1ß, Macropahge inflammatory protein (MIP)-1ß) and regulatory cytokines (IL-10, transforming growth factor (TGF)-ß, IL1ra) from peripheral blood samples collected during this trial
Time frame: 8 and 10 weeks
body weight
Time frame: 8 and 10 weeks
Marie-Christine Simon, Dipl. oecotroph.
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