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Impact of Sulphonylureas on Neurodevelopmental Outcomes in KCNJ11-related Intermediate Developmental Delay, Epilepsy and Neonatal Diabetes (iDEND) Syndrome

NCT05751525 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2024-06-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Sulfonylurea

Glibenlclamide / glyburide

Sponsors & Collaborators

  • University of Chicago

    collaborator OTHER

  • University of Bergen

    collaborator OTHER

  • University of Rome Tor Vergata

    collaborator OTHER

  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Prof Andrew Hattersley · University of Exeter / Royal Devon University Healthcare Trust

Eligibility

Min Age
2 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2025-08-01
Completion
2025-12-31

Countries

  • United States
  • Italy
  • Norway
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751525 on ClinicalTrials.gov