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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40633

Enrollment

Registered

2014-11-21

Start date

2015-02-26

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes type 1 diabetes mellitus

Interventions

daily ingestion of 4 grams of sodiumbutyrate (butifar) or placebo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes in immunity signatures in periferal blood: effect of butyrate on in monocyte-macrophage function and differences in in vitro (eg IL-6 cytokine production after bacterial stimuli)	—

Secondary

Measure	Time frame
- Changes in T cell autoimmunityl parameters in periferal blood FACS on peripheral leukocyte subsets (change in cytokine/Tr1/nTreg/Th2/Th17 subset population, cellular islet autoimmunity (CD4, CD8, GAD, IA2) and mucosa innate and adaptive immunity (CXCR3,ß7) - Beta cell function (highly sensitive C-peptide in serum after standardized breakfast meal) - 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 short-chain fatty acids - Changes in gut microbiome - Caloric intake evaluated by 1 week diet lists before visits	—

Measure

Time frame

- Changes in T cell autoimmunityl parameters in periferal blood FACS on peripheral leukocyte subsets (change in cytokine/Tr1/nTreg/Th2/Th17 subset population, cellular islet autoimmunity (CD4, CD8, GAD, IA2) and mucosa innate and adaptive immunity (CXCR3,ß7) - Beta cell function (highly sensitive C-peptide in serum after standardized breakfast meal) - 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 short-chain fatty acids - Changes in gut microbiome - Caloric intake evaluated by 1 week diet lists before visits

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)