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

NCT07820722 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 6627
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Diabete Type 2

Keywords

Semaglutide; Type 2 Diabetes Mellitus; MRI; C13 Hyperpolarized pyruvate

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At Baseline and during the second MRI scan

Secondary Outcomes (3)

• 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

Study Arms (4)

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.

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.

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.

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.

Drug: C13 Hyperpolarized pyruvate injection

Interventions

C13 Hyperpolarized pyruvate injection DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Charles Cunningham, BASc, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norberto Garcia

CONTACT

416 480 6100; norberto.garcia@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot study in patients with type II Diabetes Mellitus using control groups

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: September 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share