Diabete Type 2Early Phase 1NCT07820722
Assessing Heart and Brain Metabolism in Type II Diabetes Mellitus Patients Using Carbon-13 MRI
A Early Phase 1 study testing C13 Hyperpolarized pyruvate injection in people with Diabete Type 2, run by Sunnybrook Health Sciences Centre.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- C13 Hyperpolarized pyruvate injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Aug 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the detailed description
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).
- Conditions
- Diabete Type 2
- Being tested
- C13 Hyperpolarized pyruvate injection
- Keywords
- Semaglutide, Type 2 Diabetes Mellitus, MRI, C13 Hyperpolarized pyruvate
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C13 Hyperpolarized pyruvate injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Patients taking semaglutide and undergoing cardiac MRIs | Experimental | 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. Receives: Drug: C13 Hyperpolarized pyruvate injection |
| Group 2. Patients taking semaglutide and doing brain MRIs | Experimental | 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. Receives: Drug: C13 Hyperpolarized pyruvate injection |
| Group 3. Patients not taking semaglutide and undergoing cardiac MRIs | Placebo comparator | 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. Receives: Drug: C13 Hyperpolarized pyruvate injection |
| Group 4. Patients not taking semaglutide and undergoing brain MRIs | Placebo comparator | 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. Receives: Drug: C13 Hyperpolarized pyruvate injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At Baseline and during the second MRI scan
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At baseline and during the second MRI scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot study in patients with type II Diabetes Mellitus using control groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Cunningham, BASc, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820722
- Sponsor's protocol ID
- 6627
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Heart and Brain Metabolism in Type II Diabetes Mellitus Patients Using Carbon-13 MRI
- ClinicalTrials.gov ID
- NCT07820722
- Acronym / sponsor ID
- 6627
- Conditions
- Diabete Type 2
- Keywords
- Semaglutide, Type 2 Diabetes Mellitus, MRI, C13 Hyperpolarized pyruvate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a pilot study in patients with type II Diabetes Mellitus using control groups
| Arm | Type | Receives |
|---|---|---|
| Group 1. Patients taking semaglutide and undergoing cardiac MRIs | Experimental | Drug: C13 Hyperpolarized pyruvate injectionPrior 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. |
| Group 2. Patients taking semaglutide and doing brain MRIs | Experimental | Drug: C13 Hyperpolarized pyruvate injectionPrior 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. |
| Group 3. Patients not taking semaglutide and undergoing cardiac MRIs | Placebo comparator | Drug: C13 Hyperpolarized pyruvate injectionAt 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. |
| Group 4. Patients not taking semaglutide and undergoing brain MRIs | Placebo comparator | Drug: C13 Hyperpolarized pyruvate injectionAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C13 Hyperpolarized pyruvate injectionParticipants 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. | Drug | Group 1. Patients taking semaglutide and undergoing cardiac MRIs, Group 2. Patients taking semaglutide and doing brain MRIs, Group 3. Patients not taking semaglutide and undergoing cardiac MRIs, Group 4. Patients not taking semaglutide and undergoing brain MRIs |
Primary outcome
Change in the 13C-pyruvate
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
The difference in 13C-pyruvate between groups
Time frame: At baseline and during the second MRI scan
The difference in 13C-lactate between groups
Time frame: At baseline and during the second MRI scan
The difference in 13C-bicarbonate between groups
Time frame: At baseline and during the second MRI scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles Cunningham, BASc, PhD principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing C13 Hyperpolarized pyruvate injection in people with Diabete Type 2, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norberto Garcia (416 480 6100 ext. 683655, norberto.garcia@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 13C-pyruvate (time frame: At baseline and during the second MRI scan). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.