Impact of Sulphonylureas on Neurodevelopmental Outcomes in KCNJ11-related Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome
Status unconfirmed
Conditions studied: Neurodevelopmental Disorders, Intellectual Disability, Development Delay, ADHD, Autism Spectrum Disorder, Epilepsy
In brief
The goal of this observational study is to learn about the impact of the diabetes drug glibenclamide (glyburide) on neurodevelopment in individuals with iDEND (developmental delay, epilepsy and neonatal diabetes) due to the V59M mutation in the KCNJ11 gene. The main question it aims to answer is whether initiating sulphonylurea (SU) therapy in the first year of life results in better neurodevelopmental outcomes in affected individuals, in comparison to starting therapy later than 12 months of age. Participants will undergo a neurodevelopmental assessment comprising parental and teacher completion of standardised questionnaires, and where possible face to face neuropsychological testing. Researchers will compare the outcomes of these standardised tests in the individuals who started SU therapy \<12 months of age in comparison to those who started \>12 months of age.
Key facts
- Study ID
- NCT05751525
- Run by
- Royal Devon and Exeter NHS Foundation Trust
- People needed
- 21
- Starts
- 2016-07-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-06-13
Who can join
Age: 2 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Current age ≥2 years
- Heterozygous for a V59M mutation in the KCNJ11 gene
- Successfully transferred to oral sulphonylurea therapy
- Willing to participate
You may not qualify if…
- Never able to transfer to oral sulphonylurea therapy
- Unwilling to participate
Where it is running
- University of Chicago — Chicago, Illinois, United States (enrolling)
- University of Rome — Rome, Italy (enrolling)
- University of Bergen — Bergen, Norway (enrolling)
- University of Exeter — Exeter, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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