Effect of oral Eubacterium Hallii on postprandial glucose metabolism in males with type 2 diabetes treated with metformin

Authors
Category Primary study
Registry of TrialsNetherlands Trial Register
Year 2018
INTERVENTION: ‐ oral 10 ml active E. hallii suspension with a total concentration of 10e9 cells in 10% glycerol for 2 weeks on top of stable dosis of metformin three times daily ‐ oral 10ml glycerol 10 % (placebo) for two weeks on top of stable dosis of metformin three times daily CONDITION: Diabetes Mellitus Type 2 (DM type II), Metformin ; ; PRIMARY OUTCOME: The primary endpoint is the effect of E. hallii versus placebo on (postprandial) glucose excursions as determined by a wearable CGM glucose sensor during 14 days after the start of the intervention SECONDARY OUTCOME: Secondary endpoints are changes in (postprandial) plasma metabolites and glucose/lipids upon standardized meal in relation to changes of E. hallii and other microbiota as well as SCFA in plasma/fecal samples. Also Daily dietary intake will be monitored during the course of the study. INCLUSION CRITERIA: • Caucasian males • 21 to 69 years‐old • diagnosed with type 2 diabetes using oral metformin on a stable dose (i.e. no changes in the last three months) • no other medication use
Epistemonikos ID: b120a70712f8ee6bd250badcfcb2a32b23adc788
First added on: Aug 24, 2024