No registrations found.
ID
Source
Brief title
Health condition
type 2 diabetes
metformin
Sponsors and support
Intervention
Outcome measures
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. Also ambulatory blood pressure measurements during 24 hours will be done before and after treatment.
Background summary
With this study we aim to study if the intestinal lactate usually generated by oral metformin treatment can be used as substrate by E haliii in order to produce more butyrate and thus improve postprandial glucose handling and insulin sensitivity in patients with type 2 diabetes on stable oral metformin dosages.
Study objective
After a runic phase of 2 weeks, we will study whether cotreatment of oral E hallii once daily given for 2 weeks on top of stable metformin dosage improves (postprandial) glycemic control in DM2 subjects compared to once daily glycerol placebo with metformine
Study design
- 2 till 0 weeks (run in phase) and 0-2 weeks (active Ehallii or placebo treatment).
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
- oral 10ml glycerol 10 % (placebo) for two weeks on top of stable dosis of metformin
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
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
• 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 < 240)
• Excessive weight loss of >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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7121 |
| NTR-old | NTR7326 |
| Other | : METC 2018/112 |