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…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter will be short-chain fatty acids in feces and plasma
(acetate, propionate, butyrate) in relation to glycemic control (HbA1c and
daily insulin use) and plasma lipid profiles.
Secondary outcome
Secondary study parameters will be intestinal integrity and inflammatory tone
(measured by fecal calprotectin), intestinal bacterial translocation (by plasma
LPS-binding peptide) and plasma inflammatory markers (leukocytes, C-reactive
protein). Gut microbiome differences which will be evaluated by HIT-chip and
oral microbiome, obtained by oral mucosal swab and finally diet/caloric intake
evaluated by 1 week diet lists.
Background summary
The gut microbiome and short-chain fatty acid metabolism have been associated
with type 1 and type 2 diabetes. 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. In short, there are many clues
in the literature that the gut microbiome not only influences metabolism, but
also, through immune activation, invokes chronic inflammatory processes leading
to insulin resistance and that it can trigger auto-immunity. Key processes here
seem to be loss of bowel wall integrity, bacterial translocation and a deranged
fatty acid metabolism.
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
Observational single centre study.
Study burden and risks
Burden: 1 time delivery of fecal and urine sample. 1 blood sampling concomitant
with routine blood sampling on the outpatient clinic. Participants will be
asked to fill out a diet list daily for 1 week prior to the visit.
Risks are a. the risk of a bruise from blood sampling and b. the finding of a
previously unknown diseases. No other risks are associated with these
procedures.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
patients:
1. Definite diagnosis of type 1 diabetes i.e. positive auto-antibodies or unambiguous clinical picture
2. no concomitant medication (no statins, ACE/ATII inhibitors, PPI nor antibiotics)
3. Normal BMI: 18-25 kg/m2
4. A balanced, *western* diet (see appendix);healthy controls:
1. normal BMI
2. Caucasian
3. Balanced, 'western' diet
Exclusion criteria
patients:
1. Ambiguous clinical picture i.e. features of type 2, or other types of diabetes
2. Complications of diabetes (retinopathy/neuropathy/microalbuminuria)
3. Medication use (eg statins, ACE/ATII inhibitors, PPI).
4. Antibiotic use in the last three months
5. (Regular) use of probiotics-containing food
6. A diet that is one-sided or unusual (see appendix)
7. Medical conditions that can be expected to affect glucose metabolism or gut microbiome
8. Chronic diarrhea;Healthy controls:
1. Medication use
2. Comorbid conditions
3. Antibiotic use in the last three months
4. (regular) use of probiotics-containing food
5. A one sided or unusual diet
6. 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 |
|---|---|
| CCMO | NL44813.018.13 |