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NCT06560060Not yet recruiting

Do People With Complications of Type 1 Diabetes Mellitus Have a Different Microbiome (MARVEL)

Is the Gut Microbiome Associated With Residual Β-Cell Function and DeVElopment of Complications in Individuals With Longstanding Type 1 Diabetes Mellitus (MARVEL)

Source: ClinicalTrials.gov · Last updated 19 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 disease and nerve damage. The aim is to find ways to keep more of the functions working, avoid low blood sugar and reduce diabetes complications.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
5000 (estimated)
First submitted
15 Aug 2024
Start date
1 Sept 2024
Primary completion date
1 Oct 2043
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT number
NCT06560060

What you commit to

  • Study type: Observational
  • Planned participants: 5000
  • From 1 Sept 2024 to the primary completion date, 1 Oct 2043
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the past three months or use during the study period.

Other illness

  • Active infection during the study visit

Other

  • Inability or unwillingness to donate feces or urine.
  • Inability or unwillingness to provide informed consent.
  • Absence of a large bowel (ie colostomy)

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.