Effect of glucose on QTc interval in Type 1 diabetes
Research type
Research Study
Full title
A single centre, placebo controlled, Phase I study to evaluate the effect of glucose and moxifloxacin on cardiac repolarisation in male and female patients with type I diabetes.
IRAS ID
131596
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Richmond Pharmacology Ltd
Eudract number
2013-001612-30
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
High blood glucose levels (hyperglycaemia) and Moxifloxacin (a commonly used antibiotic) have both been shown independently to affect heart activity in healthy volunteers as recorded by ECG. i.e. Both cause prolongation of the QTc interval which is a measure of the time between the start of the Qwave and the end of the Twave during a heartbeat cycle. In this study, we want to find out whether moxifloxacin and hyperglycaemia cause QTc prolongation in Type 1 diabetic patients. We also want to assess whether C-peptide (a fragment if insulin normally found in the blood but not present in not present in the blood of Type 1 diabetics) which has the opposite effect on heart activity i.e it shortens the QTc interval will reverse the effect of QTc prolongation in Type 1 diabetes as this may be useful for preventing ’dead in bed’ syndrome also known as ‘Sudden Cardiac Death’ which is more common in diabetic patients compared to healthy volunteers.
This study will be performed in approximately 24 male and female Type 1 diabetic volunteers who are otherwise healthy. As well as ECG recordings and other safety assessments; we will measure blood glucose levels and assess how well the volunteers tolerate the treatments glucose, C-peptide and moxifloxacin and monitor any side effects.
This study is being conducted at Richmond Pharmacology Ltd only and will involve involve up to 24 Type 1 diabetic males and females, aged 20-64 years inclusive.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0216
Date of REC Opinion
5 Jul 2013
REC opinion
Further Information Favourable Opinion