Status:
RECRUITING
EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study)
Lead Sponsor:
University of Exeter
Collaborating Sponsors:
Royal Devon and Exeter NHS Foundation Trust
King's College London
Conditions:
Type1 Diabetes Mellitus
Eligibility:
All Genders
Up to 70 years
Brief Summary
Type 1 diabetes (T1D) results from destruction of insulin-producing beta cells in the pancreas by the body's own immune system (autoimmunity). It is not fully understood what causes this type of diabe...
Detailed Description
Type 1 diabetes (T1D) is a common autoimmune disease that causes destruction of pancreatic, insulin producing beta cells, leading to high blood glucose. T1D is regarded as a childhood disease with an ...
Eligibility Criteria
Inclusion
- Study 1:
- EET1D
- Aged 0 to 70 years
- Clinical diagnosis of diabetes \<24 months (+ evidence of WHO diabetes criteria)
- Negative genetic test for mutations causing non-autoimmune neonatal diabetes if diagnosed \<12 months
- Type 1 diabetes genetic risk score \>50th centile of T1D reference group, or monogenic cause of T1D.
- T1D Controls
- Age 0-70 years (matched to above)
- Clinical diagnosis of T1D (diagnosed age 1-20 years)
- Insulin treated from diagnosis.
- Monogenic / NDM controls
- Diagnosis of diabetes \<12 months
- Diagnosis of monogenic / NDM (confirmed by Exeter Molecular Genetics Laboratory).
- Study 2:
- EET1D
- Aged 0 to 24 months at recruitment
- Clinical diagnosis of diabetes \<24 months (+ evidence of WHO diabetes criteria)
- Negative genetic test for mutations causing non-autoimmune neonatal diabetes
- Type 1 diabetes genetic risk score \>50th centile of T1D reference group, or monogenic cause of T1D.
- Monogenic/NDM controls
- Diagnosis of diabetes \<24 months
- Age 0 to 18 months at recruitment
- Diagnosis of monogenic/NDM (confirmed by Exeter Molecular Genetics Laboratory).
- Non-diabetic controls
- Aged 0-6 years
- Attending specified participating hospital sites for elective surgery, including but not limited to: inguinal hernia repair, umbilical/midline hernia repair, orchidopexy, gastrostomy insertion/change, hypospadias repair, cleft palate repair, excision of accessory digit, laryngoscopy, adenoidectomy, tonsillectomy, MRI under general anaesthesia, eye surgery.
Exclusion
- Study 1:
- Aged \>70 years
- No diagnosis of diabetes
- MODY (e.g. caused by HNF1A/HNF4A/HNF1B/GCK mutations), type 2 diabetes or diabetes related to pancreatic insufficiency or syndromic diabetes
- Intercurrent illness at time of sampling for PBMCs (see below).
- Study 2:
- Aged \>24 months
- Clinical diagnosis of diabetes \>24 months
- Intercurrent illness at time of sampling for PBMCs or RNA (see below).
- Non-diabetic controls:
- Aged \>6 years
- Diagnosis of diabetes or other autoimmune condition
- Known immunological disorder
- On immunosuppressive medication
- Ongoing infections/sepsis
- Major congenital abnormality or significant systemic illness that may affect the immune system, e.g. metabolic disease, 22q deletion syndrome
- Recent (within two weeks) febrile illness
- Renal failure.
- For PBMC and RNA sampling: Exclusion for factors that may alter T cell function and RNAseq
- Review the following exclusion criteria carefully at time of appointment as some details may have changed since initial contact:
- Recreational drug use (excluding cannabis use more than 1 week prior to blood sampling) - drug abuse may alter T cell function
- Alcohol related illness (excessive alcohol consumption may alter T cell function)
- Renal failure: Creatinine \>200 (as may alter T cell function)
- Any other medical condition which, in the opinion of the investigator, would affect the safety of the subject's participation.
- Factors that if temporary would lead to rearrangement of study visit but if long duration, may lead to exclusion subject to the CI's discretion:
- Pregnant or lactating (as this may limit blood sampling and affect T cell function)
- Any infectious illness within the last 2 weeks if it was a febrile illness, or within 2-3 days if it was non-febrile (as this may activate T cells non-specifically)
- Taking steroids or other immunosuppressive medications (as these may alter T cell function)
- Received any immunoglobulin treatments or blood products in the last 3 months (as these may alter T cell function).
Key Trial Info
Start Date :
September 19 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03369821
Start Date
September 19 2017
End Date
November 30 2028
Last Update
December 19 2025
Active Locations (4)
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1
Benaroya Research Institute
Seattle, Washington, United States, 98101-2795
2
Leiden University Medical Center
Leiden, Leiden, Netherlands, 2333 ZA
3
Royal Devon & Exeter NHS Foundation Trust
Exeter, Devon, United Kingdom, EX2 5DW
4
King's College London
London, United Kingdom, SE1 9RT