Residual beta cell function and microbiome in type 1 diabetes
Recruiting
- Conditions
- type 1 diabetes
- Registration Number
- NL-OMON25270
- Lead Sponsor
- DFN-DO
- Brief Summary
will follow
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
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).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Correlation of above mentioned primary endpoints with:<br> -Frequency of Hypoglycemia<br>• Awareness of hypoglycemia<br>• presence off Diabetic complications<br>• Circulating (T cell) immune cell panel including HLA type<br>• Fecal microbial composition (illumina 16s ribosomal RNA sequencing)<br>• Plasma microbial metabolomics<br>• Sex<br>• Age<br>• Duration of type 1 diabetes<br>• Smoking<br>• Medication use<br>• Diabetic complications<br>• Abdominal complaints<br>Recorded at the study visit<br>• Blood pressure<br>• BMI<br>• Glucose time in range from continuous glucose monitoring device (Free style libre) . <br>• Serum creatinine and calculated eGFR<br>• Lipid profile (total cholesterol, HDL, LDL triglycerids)<br>• urinary Albuminuria/creatinine ratio<br>• HbA1c<br>• CRP