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Evaluation of the Effects of KCNQ1 Mutation on Insulin Tolerance and Obsessive Compulsive Features in Long QT Romano-Ward Syndrome Patients.

NCT04715256 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-20

No results posted yet for this study

Summary

The objectives of the study are to investigate if KCNQ1 mutation in Romano-Ward long QT patients can be associated with changes in insulin regulation and with psychological features of compulsivity, impulsivity and behavioural rigidity.

Conditions

  • Romano-Ward Syndrome
  • Long QT Syndrome
  • Compulsive Behavior
  • Healthy Individuals

Interventions

BEHAVIORAL

Cognitive assessment of obsessive-compulsive and impulsive behaviours

The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (attention, impulsivity) and a clinical assessment (impulsive behaviour, autistic traits,obsessive-compulsive behaviour).

GENETIC

Genomic analysis

A genome-wide association study (GWAS) will be performed for all subjects to search for associations between KCNQ1 mutations, insulin regulation and psychological features.

DIAGNOSTIC_TEST

Glucoregulation assessment

Fasted glycaemia and insulinaemia, glycated haemoglobin (HbA1c) and glycaemia following an oral glucose challenge test will be measured in all study subjects.

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Nantes University Hospital

    collaborator OTHER

  • Biotrial

    lead INDUSTRY

Principal Investigators

  • Sophie Hays, MD · Biotrial

  • Probst Vincent, MD · Nantes University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Entities

Companies

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 NCT04715256 on ClinicalTrials.gov