Oral sodium butyrate use in subjects with type 1 diabetes will lead to an altered innate immune system response, ultimately improving beta cell function and glucose regulation.
ID
Bron
Verkorte titel
Aandoening
type 1 diabetes mellitus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary study parameter will be changes in innate immunity (periferal monocyte phenotype and in vitro cytokine production) upon oral sodium butyrate treatment.
Achtergrond van het onderzoek
A reduction in ScFA butyrate-producing microbiota is associated with DM1 development. Recent literature suggests a pathway where butyrate affects bacterial translocation (altered intestinal permeability), trained (innate and adaptive) immunity in DM1 . ‘Trained immunity’ seems to be a way by which the immune system reacts to chronic exposure of intestinal microbial pathogens.. This might explain how bacterial translocation induced by lower intestinal butyrate levels leads to increased systemic inflammation and altered immune function often seen in longstandig DM1 patients.
Doel van het onderzoek
Oral sodium butyrate use in subjects with type 1 diabetes will lead to an altered innate immune system response, ultimately improving beta cell function and glucose regulation.
Onderzoeksopzet
baseline, after 4 weeks, after 8 weeks (washout) and after 12 weeks
Onderzoeksproduct en/of interventie
oral sodium butyrate during 4 weeks and placebo pills for 4 weeks
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)
Type 1 diabetes patients
male/female (18-45 years, normal BMI 19-25 kg/m2)
non smoking,
No complications (microalbuminuria, retinopathy and/or neuropathy)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
concomitant medication besides exogenous insulin., antibiotic use in the last three months, use of probiotics, comorbidity that might affect intestinal flora, chronic diarrhoea or fulfilling the criteria for irritable bowel syndrome.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4832 |
| NTR-old | NTR4955 |
| Ander register | : METC 2014_291 |