Status:
COMPLETED
Cardiac Rest and Stress Metabolism in Patients With Type 2 Diabetes
Lead Sponsor:
University of Leicester
Conditions:
Diabetes Mellitus, Type 2
Metabolic Cardiomyopathy
Eligibility:
All Genders
18+ years
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 relate...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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%
- 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.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04009642
Start Date
March 5 2018
End Date
March 1 2020
Last Update
May 3 2021
Active Locations (1)
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1
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, United Kingdom