No registrations found.
ID
Source
Brief title
Health condition
type 1 diabetes
Sponsors and support
Intervention
Outcome measures
Primary outcome
associations between residual beta cell function (2-hour post-meal urinary C-peptide / creatinine ratio), gut microbiome composition and circulating T-cell immune cell function
Secondary outcome
Correlation of above mentioned primary endpoints with:
-Frequency of Hypoglycemia
• Awareness of hypoglycemia
• presence off Diabetic complications
• Circulating (T cell) immune cell panel including HLA type
• Fecal microbial composition (illumina 16s ribosomal RNA sequencing)
• Plasma microbial metabolomics
• Sex
• Age
• Duration of type 1 diabetes
• Smoking
• Medication use
• Diabetic complications
• Abdominal complaints
Recorded at the study visit
• Blood pressure
• BMI
• Glucose time in range from continuous glucose monitoring device (Free style libre) .
• Serum creatinine and calculated eGFR
• Lipid profile (total cholesterol, HDL, LDL triglycerids)
• urinary Albuminuria/creatinine ratio
• HbA1c
• CRP
Background summary
It has become apparent that most individuals with type 1 diabetes mellitus (T1D) have some remaining beta cell function. Individuals with T1D and a preserved beta cell mass have a lower risk of hypoglycaemia and diabetic complications. The factors regulating residual beta cell function are unknown. A likely mechanism leading to a large beta cell reserve is regulation of immunological tone by the gut microbiome. Therefore, we will investigate whether residual beta cell mass is associated with gut micro-biome composition and circulating immune cell counts in individuals with T1D.
Study objective
The association between the gut microbiome/virome, T-cell exhaustion and immuno-tolerance in T1D constitutes an important knowledge gap and may serve as a therapeutic target in T1D, that will be adressed in this cohort study.
Study design
1 day (only one study visit)
Intervention
none
Inclusion criteria
All individuals with T1D visiting the outpatient clinic of recruiting centres in the greater Amsterdam region
>18 years old.
Exclusion criteria
- Active infection at the time of inclusion (not to influence immune-cell function)
• Antibiotic or proton-pump inhibitor use last 3 months (not to influence
microbiome)
• Unwillingness to donate feces, urine and/or blood
• Inability to provide informed consent based on cognitive function, language
barrier or other reasons
• Absence of large bowel (ie colostomy).
Design
Recruitment
IPD sharing statement
Plan description
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 | NL8931 |
| Other | METC AMC : 2020-105 |