Is the Gut Microbiome Associated with Residual *-Cell Function and Development of Complications in Individuals with Longstanding Type 1 Diabetes Mellitus

Conditions: Type 1 diabetes
10012653
10003816

Registration Number: NL-OMON56647

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 5000

Inclusion Criteria

-Everyone with type 1 diabetes above the age of 18

Exclusion Criteria

1. Active infection during the study visit
2. Inability or unwillingness to donate feces or urine.
3. Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in
the past three months or use during the study period.
4. Inability or unwillingness to provide informed consent.
5. Absence of a large bowel (ie colostomy)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The primary endpoint is long-term residual β-<br /><br>cell function as assessed by baseline and stimulated 2-hour post meal urinary<br /><br>C-peptide levels at 3,6 and 10 years follow-up. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint pertains presence and incidence of diabetes<br /><br>complications (cardiovascular disease, nephropathy, neuropathy and<br /><br>retinopathy), gut microbiota composition measured in feces with shotgun<br /><br>sequencing, glucose time-in-range (CGM-metrics) and subsequent exogenous<br /><br>insulin dose. Tertiary endpoints include the profiling of immune cell subsets,<br /><br>assessment of autoreactive T lymphocytes and HLA typing by high resolution<br /><br>sequencing of circulating leukocytes (IMMOCHIP) in relation to untargeted<br /><br>plasma metabolomics (Metabolon).</p><br>