type 2 diabetes metformin
Conditions
Interventions
- 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
- oral 10ml glycerol 10 % (placebo) for two weeks o
Sponsors
AMC-UvA
Eligibility
Inclusion criteria
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
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)6, 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 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
| Measure | Time frame |
|---|---|
| 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. Also ambulatory blood pressure measurements during 24 hours will be done before and after treatment. | — |
Contacts
Public ContactErik Stroes
Department of Vascular Medicine, AMC
Outcome results
None listed