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…
ID
Bron
Verkorte titel
Aandoening
type 2 diabetes
metformin
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
- 2 till 0 weeks (run in phase) and 0-2 weeks (active Ehallii or placebo treatment).
Onderzoeksproduct en/of interventie
- 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
Publiek
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
Wetenschappelijk
Erik Stroes
Amsterdam
The Netherlands
+31 (0)20 5665978
E.S.G.Stroes@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7121 |
| NTR-old | NTR7326 |
| Ander register | : METC 2018/112 |