type 2 diabetes
Conditions
Interventions
Subjects will be given oral 10 ml E. hallii suspension with a total
concentration of 10e9 cells/ml in 10% glycerol (vial A) or 10ml 10 % glycerol
only (Vial D) once daily during 14 days.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Caucasian males * 21 to 69 years-old * type 2 diabetes with the use of metformin on a stable dose (i.e. no changes in the last three months)
Exclusion criteria
Exclusion criteria: * Smoking * Alcohol abuse (>12 to 15 g of alcohol per day) * History of cardiovascular event (myocardial infarction or pacemaker implantation) * Cholecystectomy * Use of medication other than metformin, including insulin, proton pump inhibitors (PPI as this influences intestinal microbiota composition), oral anticoagulants and/or oral antibiotics in the past three months * (Expected) prolonged compromised immunity (e.g. due to recent cytotoxic chemotherapy or HIV-infection with a CD4 count 10% in the last months or have overt untreated GI disease/ abnormal bowel habits. * Levels of plasma aspartate aminotransferase and alanine aminotransferase 2.5 times or more the upper limit of the normal range
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are (postprandial) glucose excursions determined by a wearable continuous glucose monitor (CGM) during the 14 days of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the effect of oral E. hallii treatment on 4-h mixed meal test (changes in plasma metabolites , glucose and lipids) in relation to changes in fecal microbiota composition and plasma/feces SCFA collected at baseline, week 2 and week 4. Also changes in dietary intake will be monitored | — |
Countries
Netherlands
Outcome results
None listed