Actively Recruiting

Age: 6Months - 18Years
All Genders
NCT06157736

Microbiome in the Acute Stage of New Onset Paediatric Type 1 Diabetes

Led by University College Cork · Updated on 2024-05-30

100

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

A

APC Microbiome Ireland

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this observational study is to learn more about the microbiome and metabolome of children with type 1 diabetes (T1D). The main questions it aims to answer are: 1. Do the microbiome and metabolome play a role in the onset and presentation of T1D? 2. How do the microbiome and metabolome evolve during the early stages of T1D? 3. Are there are differences in the microbiome or metabolome of children who present with diabetic ketoacidosis (DKA) versus those who present without DKA, and between those who present with mild, moderate or severe DKA? 4. Is there an association between the microbiome or metabolome and glycaemic control during the first year of diagnosis? 5. Is there an association between the microbiome or metabolome and beta cell reserve after one year of T1D disease?

CONDITIONS

Official Title

Microbiome in the Acute Stage of New Onset Paediatric Type 1 Diabetes

Who Can Participate

Age: 6Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females with newly diagnosed type 1 diabetes
  • Aged between 6 months and 18 years at their first study visit
  • Parent or guardian has provided consent to participate
  • Age-appropriate assent or consent obtained for participants aged 6 to 18 years
Not Eligible

You will not qualify if you...

  • Known diagnosis of inflammatory bowel disease or another medical condition that may interfere with the microbiome
  • Complex medical or behavioral needs preventing study participation
  • Significant acute or chronic illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition contraindicating study entry
  • Receiving treatment with experimental medications
  • Participated in an experimental trial within the past 30 days
  • Having malignant disease or end-stage organ disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cork University Hospital

Cork, Ireland

Actively Recruiting

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Research Team

C

Colin Hawkes

CONTACT

E

Elaine Kennedy

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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