Assessing Heart and Brain Metabolism in Type II Diabetes Mellitus Patients Using Carbon-13 MRI
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Change in the 13C-pyruvate
研究概览
简要总结
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.
详细描述
This study aims to see how well hyperpolarized 13C-pyruvate works to image the brain and heart of T2DM patients taking semaglutide, compared to those not taking it.
Group 1: You will undergo two heart MRI scans. The first scan will take place before you begin taking semaglutide (referred to as Day 1). The second scan will occur at least 4 months after starting semaglutide. Both scans will use a special 13C pyruvate injection as a contrast agent. These MRI scans should take about 60 to 75 minutes each.
Group 2: You will undergo two brain MRI scans. The first scan will take place before you begin taking semaglutide (referred to as Day 1). The second scan will occur at least 4 months after starting semaglutide. Both scans will use a special 13C pyruvate injection as a contrast agent. These MRI scans should take about 60 to 75 minutes each.
Group 3: You will undergo two heart MRI scans. The first scan will be scheduled for a specific date, agreed upon by you and the research team (referred to as Day 1). The second scan will take place at least four months after the initial scan. Both scans will use a special 13C pyruvate injection. These MRI scans should take about 60 to 75 minutes each.
Group 4: You will undergo two brain MRI scans. The first scan will be scheduled for a specific date, agreed upon by you and the research team (referred to as Day 1). The second scan will take place at least four months after the initial scan. Both scans will use a special 13C pyruvate injection. Each MRI scan should take about 60 to 75 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •For participants in Groups 1 and 2: Prescribed a semaglutide dose of 0.5 mg S/C weekly
- •For participants in Groups 3 and 4: HbA1c between 7-9% on evidence-based medications as per the Diabetes Canada guidelines, but not GLP-1RA semaglutide
- •Written informed consent
排除标准
- •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
- •Any malignancy not considered cured, except basal cell carcinoma of the skin
- •Body mass index greater than 40.0
- •Claustrophobia and/or inability to undergo MRI without sedation
- •Contraindications to MRI as indicated on the standard MRI safety screening questionnaire
- •Participant declines or is unable to
研究组 & 干预措施
Group 1. Patients taking semaglutide and undergoing cardiac MRIs
Prior to beginning semaglutide treatment, participants will undergo cardiac MRI sequences with hyperpolarized 13C pyruvate injection. Participants will receive a second cardiac MRI exam at least 4 months post-semaglutide initiation with a second hyperpolarized 13C pyruvate injection.
干预措施: C13 Hyperpolarized pyruvate injection (Drug)
Group 2. Patients taking semaglutide and doing brain MRIs
Prior to beginning semaglutide treatment, participants will undergo brain MRI sequences with hyperpolarized 13C pyruvate injection. Participants will receive a second brain MRI exam at least 4 months post-semaglutide initiation with a second hyperpolarized 13C pyruvate injection.
干预措施: C13 Hyperpolarized pyruvate injection (Drug)
Group 3. Patients not taking semaglutide and undergoing cardiac MRIs
At baseline, participants will undergo cardiac MRI sequences with hyperpolarized 13C pyruvate injection. Participants will receive a second cardiac MRI exam at least 4 months post-baseline with a second hyperpolarized 13C pyruvate injection.
干预措施: C13 Hyperpolarized pyruvate injection (Drug)
Group 4. Patients not taking semaglutide and undergoing brain MRIs
At baseline, participants will undergo brain MRI sequences with hyperpolarized 13C pyruvate injection. Participants will receive a second brain MRI exam at least 4 months post-baseline with a second hyperpolarized 13C pyruvate injection.
干预措施: C13 Hyperpolarized pyruvate injection (Drug)
结局指标
主要结局
Change in the 13C-pyruvate
时间窗: At baseline and during the second MRI scan
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
时间窗: At baseline and during the second MRI scan
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
时间窗: At Baseline and during the second MRI scan
To measure the changes in 13C-bicarbonate in individual anatomical regions of the heart and brain by comparing pre- and post-semaglutide scans.
次要结局
- The difference in 13C-pyruvate between groups(At baseline and during the second MRI scan)
- The difference in 13C-lactate between groups(At baseline and during the second MRI scan)
- The difference in 13C-bicarbonate between groups(At baseline and during the second MRI scan)