Butyrate Use in TYpe 1 diabetes: effects on Regulation of bActerial translocation, innate immunity, T-cell function and Endotoxemia

Completed

• Conditions: diabetes; type 1 diabetes mellitus; 10012653; 10003816

• Registration Number: NL-OMON40633
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Type 1 diabetes (antiGAD en/of IA2 antibody positive)
normal body weight
normal diet

Exclusion Criteria

relevant comorbidity
recent use of antibiotics
probiotic use
retinopathy, nephropathy or neuropathy
smoking
systemic medication use except insulin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in immunity signatures in periferal blood: effect of butyrate on in<br /><br>monocyte-macrophage function and differences in in vitro (eg IL-6 cytokine<br /><br>production after bacterial stimuli)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Changes in T cell autoimmunityl parameters in periferal blood FACS on<br /><br>peripheral leukocyte subsets (change in cytokine/Tr1/nTreg/Th2/Th17 subset<br /><br>population, cellular islet autoimmunity (CD4, CD8, GAD, IA2) and mucosa innate<br /><br>and adaptive immunity (CXCR3,ß7)<br /><br>- Beta cell function (highly sensitive C-peptide in serum after standardized<br /><br>breakfast meal)<br /><br>- Glucose regulation (HbA1c and daily insulin use)<br /><br>- Intestinal and systemic inflammation (fecal calprotectin, CRP, leukocytes)<br /><br>- Bacterial translocation (LPS-binding peptide in serum)<br /><br>- Changes in fecal and serum short-chain fatty acids<br /><br>- Changes in gut microbiome<br /><br>- Caloric intake evaluated by 1 week diet lists before visits</p><br>