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出境医 / 临床实验 / Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes (CardioMET)

Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes (CardioMET)

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Metabolic Cardiomyopathy Metabolic Disturbance Fatty Acid Oxidation Disorder Other: Surely observational based on disease state

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes - The CardioMET Study
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : March 1, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Type 2 Diabetes Other: Surely observational based on disease state
Metabolism in T2DM vs non diabetic
Non Diabetic Other: Surely observational based on disease state
Metabolism in T2DM vs non diabetic
Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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)
Criteria

Inclusion Criteria:

Group 1: Type 2 diabetes cohort:

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Aged 18 years or above.
  3. Confirmed diagnosis of T2D according to World Health Organisation (WHO) criteria
  4. Undergoing invasive coronary angiography for exclusion of CAD.
  5. Able (in the investigator's opinion) and willing to comply with all study requirements
  6. Must understand written and verbal English

Group 2: Non-diabetic Controls

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Aged 18 years or above.
  3. Undergoing invasive coronary angiography for exclusion of CAD.
  4. Able (in the investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

Group 1

  1. Type 1 diabetes.
  2. Significant CAD> (50% luminal stenosis)
  3. Significant renal impairment (eGFR<30ml/min/m2).
  4. Previous coronary artery bypass grafting surgery or myocardial infarction
  5. Significant clinical established diagnosis of heart failure and EF <40%
  6. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  7. Participants who have participated in another research study involving an investigational product in the past 12 weeks
  8. Atrial fibrillation.
  9. Contra-indications to magnetic resonance imaging (pacemaker, cranial aneurysm clips, metallic ocular foreign bodies, severe claustrophobia).
  10. Known hypersensitivity to dobutamine or gadolinium.
  11. 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

  1. As per group 1 plus
  2. Diagnosis of diabetes or impaired glucose tolerance Note patients with previous CAD treated by angioplasty/stenting and no residual disease are eligible.
Contacts and Locations

Locations
Layout table for location information
United Kingdom
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Sponsors and Collaborators
University of Leicester
Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 5, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date March 5, 2018
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2019) 		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
Original Primary Outcome Measures
 (submitted: July 2, 2019) 		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 (%)= [(arterial - coronary sinus) / arterial concentration]. Concentration unit is µmol/L for FA
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes
Official Title Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes - The CardioMET Study
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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)
Condition
  • Diabetes Mellitus, Type 2
  • Metabolic Cardiomyopathy
  • Metabolic Disturbance
  • Fatty Acid Oxidation Disorder
Intervention Other: Surely observational based on disease state
Metabolism in T2DM vs non diabetic
Study Groups/Cohorts
  • Type 2 Diabetes
    Intervention: Other: Surely observational based on disease state
  • Non Diabetic
    Intervention: Other: Surely observational based on disease state
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 29, 2021) 		8
Original Estimated Enrollment
 (submitted: July 2, 2019) 		44
Actual Study Completion Date March 1, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Group 1: Type 2 diabetes cohort:

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Aged 18 years or above.
  3. Confirmed diagnosis of T2D according to World Health Organisation (WHO) criteria
  4. Undergoing invasive coronary angiography for exclusion of CAD.
  5. Able (in the investigator's opinion) and willing to comply with all study requirements
  6. Must understand written and verbal English

Group 2: Non-diabetic Controls

  1. Participant is willing and able to give informed consent for participation in the study.
  2. Aged 18 years or above.
  3. Undergoing invasive coronary angiography for exclusion of CAD.
  4. Able (in the investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

Group 1

  1. Type 1 diabetes.
  2. Significant CAD> (50% luminal stenosis)
  3. Significant renal impairment (eGFR<30ml/min/m2).
  4. Previous coronary artery bypass grafting surgery or myocardial infarction
  5. Significant clinical established diagnosis of heart failure and EF <40%
  6. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
  7. Participants who have participated in another research study involving an investigational product in the past 12 weeks
  8. Atrial fibrillation.
  9. Contra-indications to magnetic resonance imaging (pacemaker, cranial aneurysm clips, metallic ocular foreign bodies, severe claustrophobia).
  10. Known hypersensitivity to dobutamine or gadolinium.
  11. 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

  1. As per group 1 plus
  2. Diagnosis of diabetes or impaired glucose tolerance Note patients with previous CAD treated by angioplasty/stenting and no residual disease are eligible.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT04009642
Other Study ID Numbers 0633
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Leicester
Study Sponsor University of Leicester
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Leicester
Verification Date April 2021

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