Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction (Diastolic)
Diabetes
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Diabetes, T2DM, young adults, heart, weight loss, MRI, exercise, diastolic function
Eligibility Criteria
Inclusion Criteria:
- Capacity to provide informed consent before any trial-related activities
- Established T2DM (≥3months)
- HbA1c ≤ 9% if on triple therapy or ≤ 10% on diet & exercise or monotherapy or dual therapy
- Current glucose lowering therapy either mono, dual or triple of any combination of metformin, sulphonylurea, DPP-IV inhibitor, GLP-1 therapy or an SGLT2 +/- diet and exercise
- Poorly managed diet controlled diabetes (with HbA1c > 6.5% , not currently taking any glucose lowering therapy, meeting BMI inclusion range)
- Body mass index > 30Kg/m2 or > 27.5 Kg/m2 (South Asian),
- Diagnosis of T2DM before the age of 60 years of age
- Age ≥18 and ≤ 65 years
Exclusion Criteria:
- • Diabetes duration >12 years
- Currently taking more than three glucose lowering therapies
- Weight-loss of >5kg in the preceding 6 months
- Stage 4 or 5 chronic kidney disease (eGFR< 30ml/min/1.73m2),
- Current therapy with Insulin, thiazolidinediones, steroids or atypical antipsychotic medication
- Untreated thyroid disease
- Known macrovascular disease including coronary artery disease, stroke/TIA or peripheral vascular disease
- Presence of arrhythmia (including atrial fibrillation, atrial flutter, or 2nd or 3rd degree atrioventricular block)
- Known heart failure
- Other clinically relevant heart disease
- Inability to exercise or undertake a MRP
- Absolute contraindication to CMR
- Cardiovascular symptoms (angina, limiting dyspnoea during normal physical activity)
- Inflammatory condition e.g. Connective tissue disorder, Rheumatoid arthritis
Sites / Locations
- Glenfield Hospital (University Hospitals of Leicester NHS Trust)
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Experimental
Standard Care
Total Dietary Replacement
Supervised Exercise
The Standard Care group will be contacted weekly (where possible) to reinforce cognitive behavioural adaptations and encourage compliance to diet and exercise. They will be provided with standard lifestyle advice according to NICE guidance.
Group receives a total meal replacement diet from Cambridge Weight Plan containing 810 kcal/day (40% protein, 50% carbohydrate, 10% fat). The diet will be stopped, and a maintenance diet re-introduced once 50% excess body weight has been lost, or by 12 weeks, whichever comes first. The TDR will be undertaken alongside health behaviour coaching and relapse prevention contact & current medications will need to be adjusted initially and throughout the study.
The exercise group will attend thrice weekly 60minute supervised exercise sessions at the Leicester-Loughborough Diet, Lifestyle and Physical Activity (LLP) BRU or at the Leicester Diabetes Centre. An initial assessment of cardiorespiratory fitness will be performed (VO2 max) to allow design of a tailored exercise programme. Current medication will need to be adjusted initially and throughout the study.