Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Cork University Hospital
Cork, Ireland
Actively Recruiting
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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