An Early Phase 1 interventional study of C13 Hyperpolarized pyruvate injection in Diabete Type 2, sponsored by Sunnybrook Health Sciences Centre. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Sunnybrook Health Sciences Centre · Early Phase 1, Interventional, and Basic science
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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.
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.
All participants will complete standard cognitive tests within five days prior to each scan, (two assessments in total) to evaluate brain function. Alternatively, these tests may be performed on the day of the scan, prior to the procedure.
Blood samples will be collected before each scan for a total of two samples. Blood samples will be stored in a secure, access-controlled laboratory freezer at Sunnybrook Research Institute. Each sample will be labeled with a unique study code and will not contain any directly identifying information. A master code list linking study codes to participant identifiers will be stored separately in a password-protected file on a secure server, accessible only to the principal investigator and authorized study staff. Upon completion of the study and after the retention period of 15 years, all remaining blood samples will be destroyed in accordance with Sunnybrook Research Institute biosafety procedures to ensure that samples cannot be reused or linked back to participants.
All clinical procedures will be completed at Sunnybrook Health Sciences Centre (SHSC).
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
This study's planned enrollment of 32 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: C13 Hyperpolarized pyruvate injection
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.
Drug: C13 Hyperpolarized pyruvate injection
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.
Drug: C13 Hyperpolarized pyruvate injection
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.
Drug: C13 Hyperpolarized pyruvate injection
Participants 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.
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
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.
Time frame: At baseline and during the second MRI scan
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.
Time frame: At baseline and during the second MRI scan
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.
Time frame: At Baseline and during the second MRI scan
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.
Time frame: At baseline and during the second MRI scan
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.
Time frame: At baseline and during the second MRI scan
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.
Time frame: At baseline and during the second MRI scan
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2029, 34 months later.
Of 62 non-industry phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 34 months is above that.
Counting every sponsor, half of 515 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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