Impact of Glibenclamide on Neurodevelopment in iDEND Syndrome
This observational study is looking at how the diabetes medication glibenclamide (also known as glyburide) affects brain development in people with iDEND syndrome. iDEND syndrome is a condition involving developmental delay, epilepsy, and diabetes that starts in infancy, caused by a specific change (V59M mutation) in the KCNJ11 gene. The study wants to see if starting glibenclamide treatment in the first year of life leads to better neurodevelopmental outcomes compared to starting it later. You might be able to join if you are between 2 and 50 years old, have the V59M mutation in the KCNJ11 gene, and are successfully taking glibenclamide by mouth. The study will measure the number and types of neurodevelopmental and psychiatric problems, how difficult these problems are, and their impact on daily life up to two years after you join.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving new treatments. It plans to include 21 participants.
- What's involved
- Participants will undergo a neurodevelopmental assessment, which includes parents and teachers filling out questionnaires. Where possible, you may also have face-to-face neuropsychological testing.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your neurodevelopmental outcomes will be measured at or up to two years after you join the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Impact of Sulphonylureas on Neurodevelopmental Outcomes in KCNJ11-related Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome
At a glance
Conditions
Where it's being run
4 sites across 4 statesStudy leadership
- Prof Andrew Hattersley · PRINCIPAL_INVESTIGATOR · University of Exeter / Royal Devon University Healthcare Trust
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number and type of neurodevelopmental and psychiatric disordersAt or up to 2 years after recruitment
Measured by Development and Wellbeing Assessment (DAWBA)
- Level of difficulty due to neurodevelopmental and psychiatric morbidityAt or up to 2 years after recruitment
Measured by Strengths and Difficulties Questionnaire (SDQ) total difficulties score. Scores range from 0-40 with higher scores indicating greater difficulties. Scores will be converted to Z-scores using normative population data for the purposes of analysis.
- Impact on daily lifeAt or up to 2 years after recruitment
Measured by SDQ impact score. Scores range from 0-10 for parent and self-report and 0-6 for teacher report, with higher scores indicating greater difficulties. Scores will be converted to Z-scores using normative population data for the purposes of analysis.
- IQ scoreUp to 3 years after recruitment
Measured by Leiter-3 International Performance Scale