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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON24800
Enrollment
60
Registered
2014-04-15
Start date
2014-02-01
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 intestinal microbiome intestinal permeability (calprotectin) inflammatory tone

Interventions

none

Sponsors

AMC-UvA
Lead Sponsor

Eligibility

Inclusion criteria

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: 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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

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)