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QT Interval Abnormalities in Sulfonylurea Treated Type 2 Diabetes: Relationship to Treatment Induced Hypoglycaemia

NCT02298803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-02-28

Study results available
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Summary

Hypoglycaemia is the most common acute complication of diabetes and can limit therapeutic efforts to improve glycaemic control. It is a potential side effect of drugs used to treat diabetes, particularly with the use of sulfonylurea (SU) treatment. It has been demonstrated that hypoglycaemia causes the prolongation of corrected QT (QTc) interval, which is associated with ventricular arrhythmias and sudden death. Hypoglycaemia in T2DM has recently come into focus with the results of the ACCORD, ADVANCE and VADT trials.

In this study, the investigators aim to examine the association of hypoglycaemia and glucose fluctuations on QT-interval and QT variability in patients with type 2 diabetes treated with SU. Patients will be studied using simultaneous Continuous Glucose Monitoring (CGM) and ambulatory ECG monitoring (Holter).

Study participants will be recruited from the Diabetes Centre, RPAH or from specialist consulting rooms. They will be required to attend the Diabetes Centre on two occasions.

At the first visit, blood will be collected and CGM and Holter monitoring commenced. At Visit 2, i.e. two days later, the patient will return to the Diabetes Centre to have the equipment removed. The data obtained from the CGM and Holter monitor will then be downloaded for review and analysis.

Conditions

  • Diabetes Related Complications

Interventions

DEVICE

Holter and Glucose monitoring

(i) Continuous Glucose Monitoring A sterile disposable glucose-sensing sensor will be inserted into the subcutaneous tissues in either the abdomen or the upper outer quadrant of the patient's buttock. This sensor automatically measures the change in glucose in interstitial fluid every 5 minutes. The monitor will be worn for two days. (ii)Holter Monitoring The Holter monitor to capture cardiac conduction, specifically QT interval, will be worn for the same period as the continuous glucoe monitor with study participants encouraged to perform regular daily activities.

Sponsors & Collaborators

Principal Investigators

  • Ted Wu, MBBS, PhD · Royal Prince Alfred Hospital, Sydney, NSW, Australia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

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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 NCT02298803 on ClinicalTrials.gov