Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT07014735
Brief Summary:
Diabetes is a significant risk factor for sudden cardiac death, with the QTc interval on electrocardiograms (ECGs) often prolonged in diabetic patients due to factors such as hyperglycaemia and insulin resistance. Drugs like moxifloxacin can further exacerbate this effect, especially in those with diabetes. A previous trial on Type 1 diabetes suggested that hyperglycaemia and moxifloxacin have additive effects, prompting an investigation into whether similar effects occur in Type 2 diabetes (T2DM), particularly in individuals with high insulin resistance. This study aims to evaluate whether moxifloxacin-induced QT-prolongation is amplified by elevated blood glucose levels or insulin deficiency in T2DM patients, considering potential differences between sexes. Blood biomarkers will be analysed to understand the underlying molecular mechanisms. The trial will involve at least 24 male and female participants with insulin-resistant T2DM, aged 18 to 64 years, conducted at Richmond Pharmacology Ltd. Participants will receive treatments with glucose, moxifloxacin, and placebos while closely monitored for side effects during an inpatient stay, followed by outpatient appointments.
Detailed Description:
Diabetes has been established as a key independent risk factor for sudden cardiac death, a common cause of death from cardiovascular disease. The underlying mechanisms for this seem to be complex and multifactorial, but a change in the electrocardiogram (ECG)(which measures the electrical activity of the heart) parameter called QTc interval has been identified as potentially having a significant role. In patients with diabetes, QT interval prolongation is frequently reported. High blood glucose levels (hyperglycaemia) and insulin resistance (the condition where the body does not respond well to insulin) are thought to be important causes. The investigators also know that some drugs e.g., moxifloxacin (a common antibiotic) can prolong the QT interval and this effect can be more pronounced in patients with diabetes.
The investigators have previously conducted a trial on Type 1 diabetes showing that the effects of hyperglycaemia and moxifloxacin were additive. This led to our hypothesis that similar effects might be observed in type 2 diabetes (T2DM), specifically in those with high insulin resistance. Understanding whether the well-established QT-prolongation caused by moxifloxacin is exaggerated by elevated levels of blood glucose alone or by an insulin deficiency is important for evaluating the risk to patients with T2DM and the potential prevention of cardiac complications. The investigators would also like to determine if the effect varies between sexes and gain a comprehensive understanding of the molecular factors driving these differences by analysing blood biomarkers.
This trial will be conducted at Richmond Pharmacology Ltd. involving a minimum of 24 male and female participants with insulin-resistant T2DM, aged 18 to 64 years. The participants will stay in the clinical trials unit, receive treatments with glucose, moxifloxacin, and placebos and will be monitored closely for any side effects. Following the inpatient stay, participants will return to the unit for an outpatient appointment.
Study:
NCT07014735
Study Brief:
Protocol Section:
NCT07014735