oral Butyrate Use in TYpe 1 diabetes: Effects on Regulation of bActerial translocation, T-cell and innate immune system function and Endotoxemia
Completed
- Conditions
- type 1 diabetes mellitus
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method adaptive immunological parameters: FACS on peripheral T-cell subsets and mucosa innate and adaptive immunity <br> stimulated (mixed meal) beta cell function (stimuled C-peptide upon standardized mixed meal (boost) challenge in serum and urine), <br>glucose regulation (HbA1c and daily insulin use), intestinal and systemic inflammation (fecal calprotectin, CRP, leukocytes) <br>bacterial translocation (LPS-binding peptide in serum).<br>changes in fecal and serum butyrate concentrations changes in gut microbiome (HIT-chip)<br>diet/caloric intake will be evaluated by diet lists.