We hypothesize that daily oral administration of increasing dosages of Eubacterium hallii, an anaerobic intestinal bacterial strain, can exert beneficial effects on insulin sensitivity and liver fat.
ID
Bron
Verkorte titel
Aandoening
metabolic syndrome, obesity, insulin resistance, NAFLD
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Safety (plasma biochemistry eg hepatic /inflammatory/cholesterol markers) and
increase in fecal E. hallii levels upon increasing dosages of daily oral Ehallii treatment<br>
- Insulin sensitivity as assessed by hyperinsulinemic clamp using stable isotope infusion) at baseline and 4 weeks upon increasing dosages of daily oral Ehallii treatment
Achtergrond van het onderzoek
Based on our animal data, we will investigate the optimal dose of daily oral E.halliii treatment with respect to safety, improvement in insulin sensitivity (clamp) and reduced liver fat content (NAFLD/NASH on liver MRI) in male subjects with metabolic syndrome.
Doel van het onderzoek
We hypothesize that daily oral administration of increasing dosages of Eubacterium hallii, an anaerobic intestinal bacterial strain, can exert beneficial effects on insulin sensitivity and liver fat.
Onderzoeksopzet
0,1,2,4,5,6 weeks
Onderzoeksproduct en/of interventie
increasing daily dosages of eubacterium hallii (10e6, 10e8 and 10e10 cells/ml) for 4 weeks in male subjects with metabolic syndrome
Publiek
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Wetenschappelijk
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
-Caucasian obese subjects with metabolic syndrome (males, aged 21 to 69 years-old; body mass index (BMI) 25 to 43 kg/m2, fasting plasma glucose > 5.6 mmol/l, fasting triglycerides > 1.7 mmol/l, waist circumference > 102 cm)
- No concomitant medication
- Regular stool pattern
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- History of cardiovascular event (myocardial infarction or pacemaker implantation)
- Cholecystectomy
- Use of medication including proton pump inhibitors
- 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 weightloss of >10% in the last months
- Overt untreated GI disease/abnormal bowelhabits;
- Levels of plasma aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) are 2.5 times or more the upper limit of the normal range
- History of heavy alcohol use (>12 to 15 g of alcohol per day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits)
- Overt DM2
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4775 |
| NTR-old | NTR4913 |
| Ander register | : MEC 2014_215 |