Physiological effects of ketone energy fuel on the heart in diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is a single-centre, prospective, cross-sectional cohort study. The study will include type 2 diabetes patients with no history of heart or valve disease, and patients with an established heart fa
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria for diabetes patients in this study: 1. Men and women >18 years of age 2. 6.0 18 years of age 2. Ability and willingness to provide written informed consent and to comply with the requirements of the study 3. Prior diagnosis of non-ischemic heart failure 4. LV ejection fraction of 18 years of age 2. Mean HBA1c< = 6% 3. Ability and willingness to provide written informed consent and to comply with the requirements of the study
Exclusion criteria
Exclusion criteria: Exclusion criteria for diabetes patients: 1. History of coronary artery disease, previous CABG, angioplasty or myocardial infarction 2. Known HF or reduced LVEF on baseline CMR (<50%) 3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study 4. Renal impairment (eGFR <30 ml/min/m2) 5. Participation in a clinical trial in the preceding 12 weeks 6. Contra-indications to CMR or to dobutamine or gadolinium 7. Any type of diabetes other than T2D Exclusion criteria for patients with established heart failure diagnosis: 1. Significant renal impairment (eGFR <30 ml/min/m2) 2. Female participants who are pregnant, lactating or planning pregnancy during the course of the study 3. Participation in a clinical trial of an investigational medicinal product in the preceding 12 weeks 4. Contra-indications to MRI 5. Known hypersensitivity to dobutamine or gadolinium 6. History of coronary artery disease, previous CABG, angioplasty or myocardial infarction 7. Any type of diabetes other than T2D Exclusion criteria for healthy controls: 1. Any type of diabetes 2. Significant renal impairment (eGFR <30 ml/min/m2) 3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study 4. Participation in a clinical trial of an investigational medicinal product in the preceding 12 weeks 5. Contra-indications to MRI 6. Known hypersensitivity to dobutamine or gadolinium 7. History of coronary artery disease, previous CABG, angioplasty or myocardial infarction 8. Known HF or reduced LVEF on baseline CMR (<50%)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in myocardial rest, dobutamine stress, and phosphocreatine (PCr) to adenosine triphosphate (ATP) ratio following 2 weeks of ketone ester supplementation measured using magnetic resonance spectroscopy at baseline and 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial perfusion, left ventricular ejection fraction at rest and during dobutamine stress and myocardial strain (systolic strain and diastolic strain rate) measured using magnetic resonance spectroscopy at baseline and 2 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactSindhoora Kotha
Outcome results
None listed