Evaluating ImmuNe Changes in the Evolution of Pre Type 1 Diabetes With Adult ONset (INCEPTiON)
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ClinicalTrials.gov Identifier: NCT06006468 |
Recruitment Status :
Active, not recruiting
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
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Little is known about how type 1 diabetes or coeliac disease develop in adults. Studies following children at risk of type 1 diabetes from birth have shown that the marker of type 1 diabetes autoimmunity (antibodies against the insulin producing cells in the pancreas (Glutamic Acid Decarboxylase Autoantibodies (GADA), Insulin Autoantibodies (IAA), Zinc Transporter 8 Autoantibodies (ZnT8), Anti-tyrosine phosphatase-like insulinoma antigen 2 (IA-2))) can develop many years before glucose levels are raised and diabetes is diagnosed. In adults, it is unclear when antibodies develop in relation to high blood glucose levels and the diagnosis of type 1 diabetes.
Similarly in coeliac disease it is unclear to what degree Tissue transglutaminase autoantibodies (TTG) in adults proceed the development of clinically diagnosed disease.
The investigators will use samples collected and stored in The Exeter 10,000 volunteer research bank (https://exetercrfnihr.org/about/exeter-10000/) and so no new sample collection is required. This includes ~8000 participants with no history of coeliac disease or diabetes at recruitment. The investigators wish to determine prevalence of autoantibodies in the background adult population split by the highest genetic risk for type 1 diabetes and separately coeliac disease compared to a control population with lower genetic risk for these conditions. The investigators will also evaluate the proportion of these identified cases progressing to clinically diagnosed disease.
The aim of this study is to investigate evidence of autoimmunity prior to disease development and generate pilot data for the validity of screening based on genetic predisposition for type 1 diabetes and coeliac disease.
Condition or disease | Intervention/treatment |
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Type 1 Diabetes Type 1 Diabetes Mellitus Maturity Onset | Genetic: High genetic risk for type 1 diabetes Genetic: High gentic risk for Coeliac disease |
Study Type : | Observational |
Actual Enrollment : | 2250 participants |
Observational Model: | Other |
Time Perspective: | Retrospective |
Official Title: | Evaluating ImmuNe Changes in the Evolution of Pre Type 1 Diabetes With Adult Onset |
Actual Study Start Date : | February 1, 2023 |
Estimated Primary Completion Date : | August 2023 |
Estimated Study Completion Date : | December 2023 |
Group/Cohort | Intervention/treatment |
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Genetic risk of Type 1 diabetes
750 individuals with the highest type 1 diabetes genetic risk
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Genetic: High genetic risk for type 1 diabetes
in individuals without diabetes comparison of prevalence of islet auto antibodies between individuals at high genetic risk of type 1 diabetes versus controls |
Genetic risk of coeliac disease
750 individuals with the highest coeliac disease genetic risk
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Genetic: High gentic risk for Coeliac disease
in individuals without Coeliac disease comparison of prevalence of anti tissue transglutaminase antibodies between individuals at high genetic risk of coeliac disease versus controls |
Controls
750 individuals with Neutral type 1 diabetes and coeliac disease genetic risk
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Genetic: High genetic risk for type 1 diabetes
in individuals without diabetes comparison of prevalence of islet auto antibodies between individuals at high genetic risk of type 1 diabetes versus controls Genetic: High gentic risk for Coeliac disease in individuals without Coeliac disease comparison of prevalence of anti tissue transglutaminase antibodies between individuals at high genetic risk of coeliac disease versus controls |
- Number of multi-islet autoantibody positive participants [ Time Frame: through sample analysis, approx 6 months ]≥2 positive islet autoantibodies (GAD, IA-2, ZNT8, IAA) between genetic risk groups for type 1 diabetes
- Number of islet autoantibody positive participants [ Time Frame: through sample analysis, approx 6 months ]≥1 positive islet autoantibodies (GAD, IA-2, ZNT8, IAA) between genetic risk groups for type 1 diabetes
- Number of multi-islet autoantibody positive participants developing Diabetes [ Time Frame: through study follow up an average of 10 years ]number of cases developing type 1 diabetes
- Number of participants with positive Tissue transglutaminase autoantibodies [ Time Frame: through sample analysis, approx 6 months ]Number of positive Tissue transglutaminase autoantibody in genetic risk groups for coeliac disease
- Number of participants developing Coeliac disease [ Time Frame: through study follow up an average of 10 years ]number of cases developing Coeliac disease
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Exeter 10,000 study participants with stored serum samples
- Consent for samples & data to be used in further research.
Exclusion Criteria:
- Diagnosed with diabetes at time of original sample collection
- Diagnosed with coeliac disease at time of original sample collection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06006468
United Kingdom | |
NIHR Exeter Clinical Research Facility (Royal Devon University Healthcare NHS Foundation Trust) | |
Exeter, Devon, United Kingdom, EX2 5DW |
Principal Investigator: | Richard Oram, Dr | University of Exeter & Royal Devon University Healthcare NHS Foundation Trust |
Responsible Party: | Royal Devon and Exeter NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT06006468 |
Other Study ID Numbers: |
CRF525 |
First Posted: | August 23, 2023 Key Record Dates |
Last Update Posted: | August 23, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Extend data available through external application process to university of Exeter |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |