To investigate whether ingestion of 4 grams of butyrate daily during 4 weeks can positively affect the immune system function, residual betacell function and low grade inflammation in patients with type 1 diabetes mellitus.
ID
Source
Brief title
Condition
- Diabetic complications
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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
Background summary
Regulation of diabetes has shown to be related to bowel wall integrity and
bacterial translocation. Furthermore literature leads us to believe that the
intestinal microbiome might be an important pathophysiological component, in
its function or disability to provide required levels of the short-chain fatty
acid butyrate. Finally, butyrate has been shown to affect innate immune system
signatures (macrophage IL-6-production) and positively affect bowel wall
integrity and glucose regulation in mice.
Study objective
To investigate whether ingestion of 4 grams of butyrate daily during 4 weeks
can positively affect the immune system function, residual betacell function
and low grade inflammation in patients with type 1 diabetes mellitus.
Study design
Double blind randomized cross-over trial
Intervention
daily ingestion of 4 grams of sodiumbutyrate (butifar) or placebo
Study burden and risks
Daily ingestion of 4 grams of sodiumbutyrate (butifar) for one month was found
to be safe in OBUGAT study l (MEC2013_239). No risks or adverse events were
seen. Apart of vena punctie, no invasive procedures will be performed.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Type 1 diabetes (antiGAD en/of IA2 antibody positive)
normal body weight
normal diet
Exclusion criteria
relevant comorbidity
recent use of antibiotics
probiotic use
retinopathy, nephropathy or neuropathy
smoking
systemic medication use except insulin
Design
Recruitment
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 |
|---|---|
| CCMO | NL50503.018.14 |