CardioMETHeart Energy Production in Type 2 Diabetes: Fat vs. Sugar Molecules
This observational study aims to compare how efficiently the heart uses fat molecules for energy production in individuals with type 2 diabetes versus non-diabetic individuals, while at rest.
Data Collection
Collected from today forward - ProspectiveDiabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: March 5, 2018
Actual date on which the first participant was enrolled.The study focuses on understanding heart health in patients with Type 2 Diabetes. Heart failure is a common complication in diabetes, often linked to how the heart muscle produces energy. Normally, heart muscles use both sugar and fat for energy, but in people with Type 2 Diabetes, the heart might rely too heavily on fat, which is less efficient. This research aims to improve our understanding of diabetic heart disease, potentially leading to new treatment approaches. During the study, participants with Type 2 Diabetes and those without diabetes will undergo tests to measure how their hearts use sugar and fat for energy, both at rest and while the heart is working harder. This will be done by comparing blood sugar and fat levels before and after they pass through the heart. To make the heart work harder, a drug called Dobutamine is used, which mimics the effects of exercise. Heart function and blood supply will also be measured using MRI scanning. The main outcome of interest is the difference in how efficiently the heart uses fat for energy between patients with Type 2 Diabetes and those without diabetes at rest.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.8 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, United KingdomOpen Glenfield Hospital, University Hospitals of Leicester NHS Trust in Google Maps