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

NCT06560060 | Not Yet Recruiting DMC

• 1 other identifier: NL85375.018.23
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Type 1 Diabetes

Keywords

Microbiome; Type 1 diabetes; Complications; Betacell function

Outcome Measures

Primary Outcomes (1)

• Residual β-cell insulin secretion capacity:

  assessed by non-invasive 2-hour post meal c-peptide release (residual β-cell function) in urine, composed of a urinary c-peptide to creatinine ratio (UCPCR).

  At 0,3,6 and 10 years follow-up.

Secondary Outcomes (3)

• Presence and incidence of diabetes complications

  At 0, 3, 6 and 10 years follow up

• Glycemic control:

  At 0,3,6 and 10 years follow-up.

• Intestinal microbiota composition

  At 0,3,6 and 10 years follow-up.

Other Outcomes (2)

• Circulating microbiota-derived metabolites

  At 0,3,6 and 10 years follow-up.

• Autoimmunity markers

  At 0,3,6 and 10 years follow-up.

Study Arms (1)

MARVEL

5000 individuals with type 1 diabetes \> 18 years of age

Other: No intervention

Interventions

No intervention OTHER

There are no interventions. The only medical procedure is a blood draw

MARVEL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source population are patients with T1D in the Amsterdam region visiting the Diabeter Center Amsterdam which takes care for around +/- 5000 individuals with T1D.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Diabeter Nederland BV: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

EDTA plasma: Determine changes in (microbial) metabolite composition. Metabolites will be measured by Metabolon via liquid chromatography-mass spectrometry for metabolomics. Measuring Pro-insulin/glucagon via ELISA EDTA buffycoat's: Isolate DNA and perform Immunochip Heparine plasma: Look at clinical chemistry Serum: Look at proteins Citrate plasma: Coagulation testing Feces samples: DNA will be isolated and used for shotgun sequencing on an Illumina platform to determine the microbiota composition. PBMC's: DNA isolation and subsequent HLA-typing and/or epigenetic analyses. Urine sample: UCPCR measurement

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Henk-Jan Aanstoot, Dr.

  Diabeter Center Amsterdam/Diabeter Nederland

  PRINCIPAL INVESTIGATOR

• Max Nieuwdorp, Prof. Dr.

  Dept of Vascular Medicine, Amsterdam UMC - AMC

  PRINCIPAL INVESTIGATOR

• Nordin Hanssen, Dr.

  Dept of Vascular Medicine, Amsterdam UMC - AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Nieuwdorp, Prof. Dr.

CONTACT

020-5665737; m.nieuwdorp@amsterdamumc.nl

Nordin Hanssen, Dr.

CONTACT

020-5669111; n.m.j.hanssen@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof dr

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2043
• Study Completion (Estimated): October 1, 2043
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share