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ID
Source
Brief title
Health condition
type 1 diabetes
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effect on residual beta cell function as measured by stimulated C-peptide response upon mixed-meal tolerance (Boost) area under the curve (AUC0-120min) using a 2 hour mixed meal (MMT) test at 0, 6, 9 and 12 months.
Secondary outcome
Effect on Immunologic whole blood parameters (FACS) including circulating immune cell fractions and specifically measure T-cell exhaustion at 0, 6, 9 and 12 months. Also, we will use RNA seq to measure expression patterns in these cells to pinpoint which immune pathways are differentially expressed at these timepoints.
Effect on fecal microbiota composition (sequencing) and plasma and urine metabolites at 0, 6, 9 and 12 months.
Effects on the small intestinal microbiota composition as well as (histology) immunological and transcriptome changes in duodenal biopsies taken at 0 and 6 months.
Effect on clinical diabetes management( daily exogenous insulin dosage (IE/kg bw) and amount of hypoglycemia events, dietary intake and gastrointestinal complaints using questionaires at 0, 6, 9 and 12 months
Effect on glucose variability (HbA1c) as well as FreeStyle data (FSL determined time in range (TIR), hypo- and hyperglycemic episodes )measured with participants continuous glucose monitoring device at 0, 6, 9 and 12 months.
Background summary
To investigate whether fecal microbial transplantation (FMT) from donors with
type 1 diabetes and a highly preserved beta cell fraction versus placebo, administered every 8 weeks during
6 months through a small intestinal tube, preserves residual beta cell function and subsequent immunological tone up until 12
months after intervention in patients with newly diagnosed type 1 diabetes
Study objective
In this study we will investigate whether changes in gutmicrobiota composition induced by allogenic donor fecal transplantation (from longterm type 1 diabetes mellitus patients with preserved beta cell function) compared to placebo, , has beneficial effects on residual beta cell function and immune status in new onset type 1 diabetes mellitus patients. A parallel objective is to see which small (duodenal biopsy) and large intestinal (fecal samples) microbiota predict these clinical changes.
Study design
Primary endpoint:
Effect on residual beta cell function as measured by stimulated C-peptide response upon mixed-meal tolerance (Boost) area under the curve (AUC0-120min) using a 2 hour mixed meal (MMT) test at 0, 6, 9 and 12 months.
Secundary endpoints:
Effect on circulating immune cell fractions (FACS and RNAseq) and specifically measure T-cell exhaustion at 0, 6, 9 and 12 months.
Effect on fecal microbiota composition (sequencing) and plasma and urine metabolites (mass spect) at 0, 6, 9 and 12 months.
Effects on the small intestinal microbiota composition as well as (histology) immunological and transcriptome changes (gene expression) in duodenal biopsies taken at 0 and 6 months
Effect on clinical diabetes management( daily exogenous insulin dosage (IE/kg bw) and amount of hypoglycemia events, dietary intake and gastrointestinal complaints using questionaires at 0, 6, 9 and 12 months
Effect on glucose variability (HbA1c) as well as FreeStyle data (FSL determined time in range (TIR), hypo- and hyperglycemic episodes) measured with participants continuous glucose monitoring device at 0, 6, 9 and 12 months.
Intervention
allogenic donor fecal transplantation (from longterm type 1 diabetes mellitus patients with preserved beta cell function) versus placebo
Inclusion criteria
patients with <6 weeks of new onset type 1 diabetes mellitus and detectable C-peptide levels (aged 18-65 years, BMI 18-30 kg/m2, male/females, no concomitant medication).
Exclusion criteria
• Inability to provide written informed consent
• Evidence for absent residual betacel function (undetectable C-peptide)
• Antibiotics use in the last 3 months and proton-pump inhibitor use
• Evidence for compromised immunity
• Second auto-immune disease (i.e. coeliac disease, hyper- or hypothyroidism, inflammatory bowel disease)
Design
Recruitment
IPD sharing statement
Plan description
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 | NL9488 |
| Other | METC AMC : 2020_288 |