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Microbiome Characteristics and short-chain FATty acid metabolism in type 1 diabetes patients versus healthy controls


- candidate number17491
- NTR NumberNTR4514
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-apr-2014
- Secondary IDs2013-123 MEC
- Public TitleMicrobiome Characteristics and short-chain FATty acid metabolism in type 1 diabetes patients versus healthy controls
- Scientific TitleMicrobiome Characteristics and short-chain FATty acid metabolism in type 1 diabetes patients versus healthy controls
- ACRONYMMCFAT study
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 1 (DM type I), microbiomics, Intestinal permeability, Inflammation
- Inclusion criteria60 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 criteriaExclusion criteria are concomitant medication use, antibiotic use in the last three months, use of probiotics, comorbidity that might affect intestinal microbiota composition and diarrhea.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-feb-2014
- planned closingdate1-jul-2014
- Target number of participants60
- Interventionsnone
- Primary outcomeThe 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 outcomeSecondary 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).
- Timepointsone day
- Trial web site
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publicationsn/a
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD15-apr-2014 - 24-mei-2017


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