Type 2 diabetes Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
This is a single-centre, prospective, randomized, open-label mechanistic study. Type 2 diabetes (T2D) patients will be randomly assigned in a 1:1 ratio to receive either Mito-Q 40mg od for 16 weeks or
week 0) - approximately 3 hours
• Review of medical history and concomitant medications
• Review of patients' history of diabetes and complications
• Review of inclusion/exclusion criteria
• Collectio
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women >18 years of age 2. T2D patients with the ability and willingness to provide written informed consent and to comply with the requirements of the study
Exclusion criteria
Exclusion criteria: 1. Any type of diabetes other than T2D 2. Cardioverter defibrillator or a pacemaker implant 3. Cardiac amyloidosis 4. Known heart failure 5. Established significant renal impairment on routine clinical assessments (eGFR <60 ml/min/m2) 6. Participation in a clinical trial of an investigational medicinal product (CTIMP) in the preceding 12 weeks 7. Known hypersensitivity to dobutamine or gadolinium or any other contra-indications to MRI 8. Female participants who are pregnant, lactating or planning pregnancy during the course of the study 9. Known prior allergic reaction to mitoquinone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in myocardial resting PCr/ATP ratio (a sensitive indicator of myocardial energy levels) measured using MRI after 16 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes measured using MRI are assessed at 16 weeks: 1. Percent difference in myocardial PCr/ATP from rest to stress 2. Myocardial blood flow (rest and stress myocardial blood flow) 3. Global longitudinal strain 4. Biventricular ejection fraction 5. Diastolic function (mitral inflow E/A ratio) | — |
Countries
England, United Kingdom
Contacts
Public ContactHenry Procter
Outcome results
None listed