type 1 diabetes mellitus intestinal microbiome intestinal permeability (calprotectin) inflammatory tone
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 60 Type 1 diabetes subjects (male/female, 18-70 years, normal BMI (18-25kg/m2).), without complications (microalbuminuria, retinopathy and/or neuropathy) and no concomitant medication besides exogenous insulin. Also 60 matched healthy treatment naive controls for sex and age will be included
Exclusion criteria
Exclusion criteria: Exclusion criteria are concomitant medication use, antibiotic use in the last three months, use of probiotics, comorbidity that might affect intestinal microbiota composition and diarrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter will be changes between Dm1 and controls in short-chain fatty acids in relation to gutmicrobiota composition and metabolic parameters including glycemic control (HbA1c and daily insulin use) and plasma lipid profiles. Fecal microbiome differences which will be evaluated by HIT-chip and diet/caloric intake evaluated by 1 week online diet lists. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are changes between Dm1 and controls in intestinal integrity (measured by fecal calprotectin), endotoxemia (by plasma LPS-binding peptide) and plasma inflammatory markers (leukocytes, C-reactive protein). | — |
Contacts
AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2