Diabetes Mellitus, Type 2CardioMETNCT04009642
Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes
An observational study of Diabetes Mellitus, Type 2 and Metabolic Cardiomyopathy, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The number of people with diabetes is rising. One of the major causes of premature death in diabetes is heart failure (HF). This is when the heart cannot pump blood effectively, and this may be related to abnormalities in energy production in the heart muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Metabolic Cardiomyopathy, Metabolic Disturbance
- What is being tested?
- Surely observational based on disease state
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2018to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Group 1. Patients with T2D and no significant CAD (<50% luminal stenosis on coronary angiography) Group 2. Non-diabetic individuals with no significant CAD (<50% luminal stenosis on coronary angiography)
Who may be able to join
- Group 1: Type 2 diabetes cohort:
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
- Confirmed diagnosis of T2D according to World Health Organisation (WHO) criteria
- Undergoing invasive coronary angiography for exclusion of CAD.
- Able (in the investigator's opinion) and willing to comply with all study requirements
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- Must understand written and verbal English
- Group 2: Non-diabetic Controls
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
- Undergoing invasive coronary angiography for exclusion of CAD.
- Able (in the investigator's opinion) and willing to comply with all study requirements.
Who cannot join
- Group 1
- Type 1 diabetes.
- Significant CAD> (50% luminal stenosis)
- Significant renal impairment (eGFR<30ml/min/m2).
- Previous coronary artery bypass grafting surgery or myocardial infarction
- Significant clinical established diagnosis of heart failure and EF <40%
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- Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks
- Atrial fibrillation.
- Contra-indications to magnetic resonance imaging (pacemaker, cranial aneurysm clips, metallic ocular foreign bodies, severe claustrophobia).
- Known hypersensitivity to dobutamine or gadolinium.
- Participants with a diagnosis of significant (>moderate,) valve disease.
- 1. Patients who are on Insulin therapy, or oral Thiazolidinedione. 2. Involvement in other studies thought to compromise resulting study data or the health of the participant in the opinion of investigator.
- Group 2
- As per group 1 plus
- Diagnosis of diabetes or impaired glucose tolerance Note patients with previous CAD treated by angioplasty/stenting and no residual disease are eligible.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester
About this study
Official title: Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes - The CardioMET Study
The number of people with diabetes is rising. One of the major causes of premature death in diabetes is heart failure (HF). This is when the heart cannot pump blood effectively, and this may be related to abnormalities in energy production in the heart muscle. In healthy people, the heart muscle cells show flexibility and can use both sugar and fat molecules for energy production. Although burning fat provides more energy, this process requires more oxygen than burning sugars. As a result, fat is a less efficient fuel for the heart compared to sugars, especially in situations where the energy and oxygen needs are higher, such as during exercise. The investigators propose that the heart muscle in patients with type 2 diabetes relies heavily on fat for energy provision, and fails to burn more sugar molecules for energy provision during exercise to more efficiently use oxygen. Fat and sugar uptake by the heart can be detected by the difference between the blood sugar and fat levels delivered to the heart and returning from the heart, both at rest and also when the heart is working faster during Dobutamine infusion. Dobutamine is a drug frequently used to mimic exercise, and get the heart running faster during medical tests. To test the hypothesis, the investigators will assess fat and sugar uptake by the heart at rest and when the heart is running faster, in patients with type 2 diabetes undergoing investigations to rule out coronary disease. Heart function, and blood supply to heart muscle, at rest and during Dobutamine infusion, will also be measured using MRI scanning. The same tests will be performed in people without diabetes for comparison. It will help understand diabetic heart disease and which aspects may be targeted with new treatments.
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Cardiomyopathy, Metabolic Disturbance, Fatty Acid Oxidation Disorder
- Being tested
- Surely observational based on disease state
- 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.
Surely observational based on disease stateOther
Metabolism in T2DM vs non diabetic
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Not described Receives: Other: Surely observational based on disease state | |
| Non Diabetic | Not described Receives: Other: Surely observational based on disease state |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in myocardial FA extraction fraction (%) between T2D patients and non-diabetic controls at rest.
Myocardial extraction fraction
Measured: Immediate at rest and stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start5 Mar 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04009642
- Sponsor's protocol ID
- 0633
- Acronym
- CardioMET
- Status last verified
- Apr 2021
- First submitted
- 2 Jul 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes - The CardioMET Study
- ClinicalTrials.gov ID
- NCT04009642
- Acronym / sponsor ID
- CardioMET / 0633
- Conditions
- Diabetes Mellitus, Type 2, Metabolic Cardiomyopathy, Metabolic Disturbance, Fatty Acid Oxidation Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 5 Jul 2019 (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.
The number of people with diabetes is rising. One of the major causes of premature death in diabetes is heart failure (HF). This is when the heart cannot pump blood effectively, and this may be related to abnormalities in energy production in the heart muscle. In healthy people, the heart muscle cells show flexibility and can use both sugar and fat molecules for energy production. Although burning fat provides more energy, this process requires more oxygen than burning sugars. As a result, fat is a less efficient fuel for the heart compared to sugars, especially in situations where the energy and oxygen needs are higher, such as during exercise. The investigators propose that the heart muscle in patients with type 2 diabetes relies heavily on fat for energy provision, and fails to burn more sugar molecules for energy provision during exercise to more efficiently use oxygen. Fat and sugar uptake by the heart can be detected by the difference between the blood sugar and fat levels delivered to the heart and returning from the heart, both at rest and also when the heart is working faster during Dobutamine infusion. Dobutamine is a drug frequently used to mimic exercise, and get the heart running faster during medical tests. To test the hypothesis, the investigators will assess fat and sugar uptake by the heart at rest and when the heart is running faster, in patients with type 2 diabetes undergoing investigations to rule out coronary disease. Heart function, and blood supply to heart muscle, at rest and during Dobutamine infusion, will also be measured using MRI scanning. The same tests will be performed in people without diabetes for comparison. It will help understand diabetic heart disease and which aspects may be targeted with new treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | Other: Surely observational based on disease state |
| Non Diabetic | – | Other: Surely observational based on disease state |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1. Patients with T2D and no significant CAD (<50% luminal stenosis on coronary angiography) Group 2. Non-diabetic individuals with no significant CAD (<50% luminal stenosis on coronary angiography)
Key inclusion criteria (12 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Aged 18 years or above.
- Confirmed diagnosis of T2D according to World Health Organisation (WHO) criteria
- Undergoing invasive coronary angiography for exclusion of CAD.
- Able (in the investigator's opinion) and willing to comply with all study requirements
Key exclusion criteria (16 listed)
- Group 1
- Type 1 diabetes.
- Significant CAD> (50% luminal stenosis)
- Significant renal impairment (eGFR<30ml/min/m2).
- Previous coronary artery bypass grafting surgery or myocardial infarction
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 |
|---|---|---|
| Surely observational based on disease stateMetabolism in T2DM vs non diabetic | Other | Non Diabetic, Type 2 Diabetes |
Primary outcome
The difference in myocardial FA extraction fraction (%) between T2D patients and non-diabetic controls at rest.
Time frame: Immediate at rest and stress
Myocardial extraction fraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Metabolic Cardiomyopathy, run by University of Leicester at 1 site in United Kingdom.
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 12 inclusion and 16 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: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in myocardial FA extraction fraction (%) between T2D patients and non-diabetic controls at rest. (time frame: Immediate at rest and stress). 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 3 May 2021.