No registrations found.
ID
Source
Brief title
Health condition
type 1 diabetes mellitus
intestinal microbiome
intestinal permeability (calprotectin)
inflammatory tone
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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).
Background summary
The gut microbiome and short-chain fatty acid metabolism have been associated with diabetes melltus. Children with beta-cell autoimmunity at risk of developing DM1 are characterized by decreased fecal concentrations of butyrate-producing bacteria, whereas absolute decreases in butyrate-producing bacteria concentrations were also reported in a small group of long term diagnosed DM1 patients. Furthermore, a recent mouse study points out that an interaction between the gut microbiome and the innate immune system is an essential factor in developing type 1 diabetes. We thus will investigate in 60 uncomplicated Dm1 subjects (m/f) and 60 healthy controls whether gutmicrobiota composition is different between these groups and this correlates with short chain fatty acid concentrations, markers of metabolism and s chronic inflammatory processes including bacterial translocation.
Study objective
To investigate the differences in short-chain fatty acid metabolism, markers of local (intestinal) and systemic inflammation and markers of bacterial translocation between type-1-diabetes patients and healthy controls and to relate these differences to variations in the intestinal microbiome.
Study design
one day
Intervention
none
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
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 are concomitant medication use, antibiotic use in the last three months, use of probiotics, comorbidity that might affect intestinal microbiota composition and diarrhea.
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 |
|---|---|
| NTR-new | NL4383 |
| NTR-old | NTR4514 |
| Other | MEC : 2013-123 |