N/A
N=30
QT Interval Abnormalities in Sulfonylurea Treated Type 2 Diabetes: Relationship to Treatment Induced Hypoglycaemia
Diabetes Related Complications
Bottom Line
View on ClinicalTrials.gov: NCT02298803 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Change in the Corrected QT-interval During Nocturnal Hypoglycemia — 3; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Holter and Glucose monitoring (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Royal Prince Alfred Hospital, Sydney, Australia
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Corrected QT-interval During Nocturnal Hypoglycemia |
3; 5 | — |
| PRIMARY Change in Corrected QT Interval During Day Time Hypoglycaemia |
2; 1 | — |
| SECONDARY Pearson's Correlation Coefficient of Delta QTc and a Measure of Glucose Variability, MAGE (Mean Amplitude of Glycemic Excursion). |
0.09 | — |
| SECONDARY Mean Amplitude of Glycemic Excursion (MAGE) |
3.9; 4.7; 3.0; 3.9; 1.8; 3.6 | — |
| SECONDARY deltaQTc |
10; 4; -2; -6; -4; -1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes
- A history of symptomatic or documented hypoglycaemia
- Currently treated with a sulphonylurea ± any anti-diabetic agent/s other than insulin
- Currently performing home blood glucose monitoring and willing to do seven tests a day during the study period
Exclusion Criteria
- Type 1 diabetes
- Current treatment with insulin
- LBBB and conduction anomalies that preclude QT analysis
- Drugs that prolong QT interval
- Family history of Long QT syndrome
Data sourced from ClinicalTrials.gov (NCT02298803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.