Do People With Complications of Type 1 Diabetes Mellitus Have a Different Microbiome (MARVEL) (NCT06560060) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Do People With Complications of Type 1 Diabetes Mellitus Have a Different Microbiome (MARVEL)
5,000 participantsStarted 2024-09-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Residual β-cell insulin secretion capacity:
Timeframe: At 0,3,6 and 10 years follow-up.
Trial details
NCT IDNCT06560060
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)