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NCT07820722Not yet recruitingEarly phase 1

Assessing Heart and Brain Metabolism in Type II Diabetes Mellitus Patients Using Carbon-13 MRI

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
32 (estimated)
First submitted
11 Aug 2026
Start date
1 Oct 2026
Primary completion date
1 Aug 2029
Lead sponsor
Sunnybrook Health Sciences Centre
NCT number
NCT07820722

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 32
  • From 1 Oct 2026 to the primary completion date, 1 Aug 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • 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

Other

  • Participants on anticonvulsants, benzodiazepines, immunosuppressants and/or antiarrhythmics
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.