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oral Butyrate Use in TYpe 1 diabetes: Effects on Regulation of bActerial translocation, T-cell and innate immune system function and Endotoxemia


- candidate number21366
- NTR NumberNTR4955
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jan-2015
- Secondary IDsMETC 2014_291 
- Public Titleoral Butyrate Use in TYpe 1 diabetes: Effects on Regulation of bActerial translocation, T-cell and innate immune system function and Endotoxemia
- Scientific Titleoral Butyrate Use in TYpe 1 diabetes: Effects on Regulation of bActerial translocation, T-cell and innate immune system function and Endotoxemia
- ACRONYMBUTYRATE trial
- hypothesis 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I)
- Inclusion criteriaType 1 diabetes patients male/female (18-45 years, normal BMI 19-25 kg/m2) non smoking, No complications (microalbuminuria, retinopathy and/or neuropathy)
- Exclusion criteriaconcomitant 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2015
- planned closingdate1-feb-2016
- Target number of participants30
- Interventionsoral sodium butyrate during 4 weeks and placebo pills for 4 weeks
- Primary outcomeThe primary study parameter will be changes in innate immunity (periferal monocyte phenotype and in vitro cytokine production) upon oral sodium butyrate treatment.
- Secondary outcomeadaptive 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.
- Timepointsbaseline, after 4 weeks, after 8 weeks (washout) and after 12 weeks
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam, University of Amsterdam (UvA)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publicationsn/a
- Brief summaryA 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.
- Main changes (audit trail)
- RECORD8-jan-2015 - 24-mei-2017


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