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MARVEL cohort

Is the Gut Microbiome Associated with Residual ?-Cell Function and Development of Complications in Individualswith Longstanding Type 1 Diabetes Mellitus - MARVEL cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56647
Enrollment
5000
Registered
2023-09-21
Start date
2024-10-15
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes Type 1 diabetes

Interventions

5000 individuals with type 1 diabetes &gt
18 years of age, visiting the outpatient clinic of Diabeter center Amsterdam and DiabeterNederland.

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Everyone with type 1 diabetes above the age of 18

Exclusion criteria

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 useduring the study period. 4. Inability or unwillingness to provide informed

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: The primary endpoint is long-term residual ß-cell function as assessed by baseline and stimulated2-hour post meal urinary C-peptide levels at 3,6 and 10 years follow-up.

Secondary

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

Countries

Netherlands

Contacts

Public ContactM Nieuwdorp

Amsterdam UMC

m.nieuwdorp@amsterdamumc.nl(020-73) 28950

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)