NCT02775513

Brief Summary

Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS) due to a prolonged cardiac repolarisation phase. Hypoteses: patients with loss-of-function mutations also exhibit altered hormone release upon glucose ingestion.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

5.7 years

First QC Date

March 16, 2016

Last Update Submit

May 13, 2016

Conditions

Long QT Syndrome

Outcome Measures

Primary Outcomes (1)

  • glucose homeostasis

    measured by glucose, insulin, glucagon, GLP-1 and GIP response to glucose (OGTT)

    6 hours

Secondary Outcomes (1)

  • QT

    6 hours

Study Arms (2)

Mutation

Patients with functional mutation in ion channels

Control

Matched control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with functional mutations in ion channels and matched healthy controls

You may qualify if:

  • LQTS Gain of function Matched healthy controls

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hylten-Cavallius L, Iepsen EW, Wewer Albrechtsen NJ, Svendstrup M, Lubberding AF, Hartmann B, Jespersen T, Linneberg A, Christiansen M, Vestergaard H, Pedersen O, Holst JJ, Kanters JK, Hansen T, Torekov SS. Patients With Long-QT Syndrome Caused by Impaired hERG-Encoded Kv11.1 Potassium Channel Have Exaggerated Endocrine Pancreatic and Incretin Function Associated With Reactive Hypoglycemia. Circulation. 2017 May 2;135(18):1705-1719. doi: 10.1161/CIRCULATIONAHA.116.024279. Epub 2017 Feb 24.

    PMID: 28235848DERIVED

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 16, 2016

First Posted

May 17, 2016

Study Start

September 1, 2010

Primary Completion

May 1, 2016

Last Updated

May 17, 2016

Record last verified: 2016-05