Status:
NOT_YET_RECRUITING
Do People With Complications of Type 1 Diabetes Mellitus Have a Different Microbiome (MARVEL)
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Diabeter Nederland BV
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
This study looks at whether people with type 1 diabetes have different gut bacteria. We also want to see if this is linked to keeping insulin production up and preventing complications like heart dise...
Detailed Description
Rationale: It has become apparent that most individuals with type 1 diabetes mellitus (T1D) have some remaining β-cell function. Individuals with T1D and a preserved β-cell function have a lower risk ...
Eligibility Criteria
Inclusion
- All individuals with T1D visiting the outpatient clinic of Diabeter Center Amsterdam or Diabeter Nederland are potentially eligible if they are \>18 years old.
- T1D diagnosis is made by the primary clinician prior to the study visit. Presence of auto- antibodies at time of diagnosis will be recorded.
Exclusion
- Active infection during the study visit
- Inability or unwillingness to donate feces or urine.
- Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.
- Inability or unwillingness to provide informed consent.
- Absence of a large bowel (ie colostomy)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2043
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06560060
Start Date
September 1 2024
End Date
October 1 2043
Last Update
August 19 2024
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