NCT06478121 Understanding Beta Cell Disorders Through the Study of Rare Genotypes (ENDURE)
| NCT ID | NCT06478121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Exeter |
| Condition | Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2029-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-11-11 with a primary completion date of 2029-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This observational 'recruit by genotype' study aims to provide insights into the cellular and molecular pathways underlying beta cell disorders and their physiological consequences. Eligible individuals are those with and without a pathogenic genetic variant, acting as case and control, respectively. Using a "recruit by genotype" approach, the researchers will perform detailed and specific analysis according to the individual's genetic variant. The study's main aims are to : 1) identify and describe biomarkers and cellular features in blood samples that occur because of the rare causal genetic variant; 2) study the altered physiology or cellular function that are due to the rare causal genetic variant. Participants will attend a study visit that will entail: * Consent * Data collection * Height and weight measures * Blood samples * MRI (optional), dependent on genotype and sub-study objectives. There is no treatment and the participants' normal clinical care will be unaffected and will continue uninterrupted. A small subset of participants may be invited for further sub-studies in the future. Researchers may recruit sex-matched healthy controls (without the variant of interest) with similar age and BMI (age: +/-15%, BMI: +/- 3 kg/m2) for specified case-control studies.
Eligibility Criteria
Inclusion Criteria * Mental capacity to give informed consent * Of any sex, ethnicity, location. * Group 1: Cases will have a genetic variant(s) resulting in a beta cell disorder. * Group 2: Controls will not have a genetic variant(s) resulting in a beta cell disorder and will be matched to a Case for sex, age (+/- 15%) and BMI (+/- 3 kg/m2). Exclusion Criteria * Lack of mental capacity to give informed consent * Age \<6 years; \>99 years Additional exclusions for MRI assessments: * Cochlear Implant * Aneurysm Clips * Neurological stimulator * Implanted cardiac devices (ICD, PPM, loop recorders, or any others) * Metal heart valve * History of metal foreign bodies in orbits * Other implanted metal device which prevents MRI * Known claustrophobia.
Contact & Investigator
Andrew Hattersley, FRS, FMed
PRINCIPAL INVESTIGATOR
University of Exeter
Frequently Asked Questions
Who can join the NCT06478121 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 99 Years, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06478121 currently recruiting?
Yes, NCT06478121 is actively recruiting participants. Contact the research team at m.johnson@exeter.ac.uk for enrollment information.
Where is the NCT06478121 trial being conducted?
This trial is being conducted at Exeter, United Kingdom.
Who is sponsoring the NCT06478121 clinical trial?
NCT06478121 is sponsored by University of Exeter. The principal investigator is Andrew Hattersley, FRS, FMed at University of Exeter. The trial plans to enroll 50 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.