There has been a notable increase in the number of Canadians living with type II diabetes. People with this type of diabetes often have high levels of a substance called lactate in their blood, which might be linked to problems with thinking and heart failure.
A new imaging technique has been developed that can help us see how lactate is being processed in the body. This involves using MRI technology to rapidly look at chemical reactions happening inside cells. This new method uses a special contrast agent that's injected into the body, which produces a much stronger magnetic signal, making it easier to see what's happening inside.
In this study, we will use this new imaging method with a substance called carbon-13 pyruvate to monitor how it changes in the brain and heart of people with type II diabetes. We will also see how these changes relate to their treatment with a medication called semaglutide.
This new MRI method has been used to study cancer, the brain and heart in human participants, but not in T2DM patients. The data we collect might help doctors improve the treatment of patients with T2DM, heart failure, dementia, and cognitive problems in the future.
Health Canada has not approved the use of 13C-enriched pyruvate for use or sale for any condition, although they have allowed its use in this research study.
Adult participants of all ethnic groups/race categories (≥ 18 years of age)
Blood lactate ≥ 2 mmol/L ≤ 5 mmol/L
Blood pressure target < 130/80
No history of macrovascular or microvascular disease
History of macrovascular or microvascular disease
Automatic implantable cardiac-defibrillators (AICD) or pacemaker, either at time of study or required within 3 months of the study
Participants on anticonvulsants, benzodiazepines, immunosuppressants and/or antiarrhythmics
Any clinically significant or unstable medical condition that might limit their ability to complete the study
Parallel
C13 Hyperpolarized pyruvate injection
DrugParticipants will be injected with a 0.1 mmol/kg dose of hyperpolarized 13C pyruvate that is used as a contrast agent. The investigational medicinal product (IMP) hyperpolarized 13C pyruvate will be intravenously injected at a rate of 4 ml/second, followed by a 25 ml saline flush at 5 ml/second. Following injection, axial 3D gradient echo 13C sequences will be acquired using the applicable 13C imaging coil.
Change in the 13C-pyruvate
To measure changes in 13C-pyruvate in individual anatomical regions of the heart and brain by comparing pre- and post-semaglutide scans.
Changes in 13C-lactate
To measure the changes in 13C-lactate in individual anatomical regions of the heart and brain by comparing pre- and post-semaglutide scans.
Change in 13C-bicarbonate
To measure the changes in 13C-bicarbonate in individual anatomical regions of the heart and brain by comparing pre- and post-semaglutide scans.
The difference in 13C-pyruvate between groups
To measure the difference in 13C pyruvate between groups in anatomical regions of the heart and brain by comparing pre- and post-semaglutide scans.
The difference in 13C-lactate between groups
To measure the difference in 13C-lactate between groups in anatomical regions of the heart and brain by comparing pre- and post-semaglutide scans.
The difference in 13C-bicarbonate between groups
To measure the difference in 13C-bicarbonate between groups in anatomical regions of the heart and brain by comparing pre- and post-semaglutide scans.
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