No registrations found.
ID
Source
Brief title
Health condition
type 1 diabetes mellitus
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter will be changes in innate immunity (periferal monocyte phenotype and in vitro cytokine production) upon oral sodium butyrate treatment.
Secondary outcome
adaptive immunological parameters: FACS on peripheral T-cell subsets and mucosa innate and adaptive immunity
stimulated (mixed meal) beta cell function (stimuled C-peptide upon standardized mixed meal (boost) challenge in serum and urine),
glucose regulation (HbA1c and daily insulin use), intestinal and systemic inflammation (fecal calprotectin, CRP, leukocytes)
bacterial translocation (LPS-binding peptide in serum).
changes in fecal and serum butyrate concentrations changes in gut microbiome (HIT-chip)
diet/caloric intake will be evaluated by diet lists.
Background summary
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.
Study objective
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.
Study design
baseline, after 4 weeks, after 8 weeks (washout) and after 12 weeks
Intervention
oral sodium butyrate during 4 weeks and placebo pills for 4 weeks
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
Inclusion criteria
Type 1 diabetes patients
male/female (18-45 years, normal BMI 19-25 kg/m2)
non smoking,
No complications (microalbuminuria, retinopathy and/or neuropathy)
Exclusion criteria
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.
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 | NL4832 |
| NTR-old | NTR4955 |
| Other | : METC 2014_291 |