Diabetes, Exercise and Liver Fat (DELIVER) ((DELIVER))
Type 2 Diabetes Mellitus, Non-Alcoholic Fatty Liver Disease, Obesity
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes, Non-alcohol fatty liver disease, Exercise, Saturated fat, MRI, Proton magnetic resonance spectroscopy
Eligibility Criteria
Inclusion Criteria:
- Men
- ≥ 30 - ≤ 75 years of age
- Body mass index ≥ 27 - ≤ 45 kg/m2 (or ≥ 23 to 45 45 kg/m2 if south Asian)
- Waist circumference ≥ 94 cm (or ≥ 90 cm if south Asian)
- Clinically elevated liver fat (≥ 5.56% assessed via 1H-MRS)
- Participant is willing and able to give informed consent to participate
- Participant can communicate effectively in English
- Participant is able to meet the time demands of the study
Additional criteria for participants without T2DM:
• HbA1c > 6.0%
Additional criteria for participants with T2DM/prediabetes:
- Diagnosed T2DM or prediabetes
- Treatment via lifestyle or metformin only within the last 6 months
- HbA1c 6.0 - 10%
- Able to meet the time and physical demands encompassed within the exercise training intervention
Exclusion Criteria:
- Contraindications to magnetic resonance procedures
- Contraindications to exercise training
- Participating in regular purposeful exercise training of vigorous intensity - frequency greater than or equal to 3 sessions per week and intensity greater than or equal to 6.0 metabolic equivalents (METs)
- Weight instability or planned/ on-going dietary intervention
- Unable to communicate sufficiently in English
- Co-morbidity that the research team determine to be a contraindication to involvement
- Current smoker
- Uncontrolled hypertension - systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg
Additional criteria for participants with T2DM/prediabetes:
- Taking additional oral anti-diabetic medications to metformin e.g. SGLT2i, GLP-1RA, DPP4 inhibitors, TZDs within the last 6 months
- Taking insulin
Sites / Locations
- University Hospitals of Leicester Nhs Trust
- NIHR Clinical Research Network
- Sir Peter Mansfield Imaging Centre
- Nottingham University Hospitals Nhs Trust
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Exercise
Control
Participants randomised to the exercise training intervention will complete 24 moderate-intensity exercise training sessions over the subsequent six weeks (four times per week; ~50 min per session). Each week, one exercise training session will be supervised by the research team, whilst three sessions will be unsupervised but monitored objectively using a heart rate monitor.
Participants randomised to control will receive no interventions and will be requested to maintain their habitual lifestyle during the six week intervention phase