oral Butyrate Use in TYpe 1 diabetes: Effects on Regulation of bActerial translocation, T-cell and innate immune system function and Endotoxemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26759

Enrollment

Registered

2015-01-08

Start date

2015-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

type 1 diabetes mellitus

Interventions

oral sodium butyrate during 4 weeks and placebo pills for 4 weeks

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary study parameter will be changes in innate immunity (periferal monocyte phenotype and in vitro cytokine production) upon oral sodium butyrate treatment.	—

Secondary

Measure	Time frame
adaptive immunological parameters: FACS on peripheral T-cell subsets and mucosa innate and adaptive immunity stimulated (mixed meal) beta cell function (stimuled C-peptide upon standardized mixed meal (boost) challenge in serum and urine), 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 butyrate concentrations changes in gut microbiome (HIT-chip) diet/caloric intake will be evaluated by diet lists.	—

Measure

Time frame

adaptive immunological parameters: FACS on peripheral T-cell subsets and mucosa innate and adaptive immunity stimulated (mixed meal) beta cell function (stimuled C-peptide upon standardized mixed meal (boost) challenge in serum and urine), 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 butyrate concentrations changes in gut microbiome (HIT-chip) diet/caloric intake will be evaluated by diet lists.

—

Contacts

Public ContactM. Nieuwdorp

AFDELING INWENDIGE GENEESKUNDE AMC MEIBERGDREEF 9, KAMER F4.159.2

m.nieuwdorp@amc.uva.nl+31 (0)20 5666612

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)