Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction

Summary

There is an epidemic of type 2 diabetes in younger adults. These patients are at very high lifetime risk of heart-related complications. Subtle heart abnormalities can be present even at a young age in these patients and may predispose them to heart failure and ultimately premature death. There is emerging evidence that type 2 diabetes can be reversed with weight loss. We propose that weight loss can also reverse the fatty changes seen in the liver and heart in these patients, and in turn lead to improved heart function. This project aims to identify how type 2 diabetes causes changes in the heart in young people with type 2 diabetes by performing detailed scans and other tests of the heart's structure and function. In addition we will attempt to see if the heart's pumping function can be improved, either by a weight loss program with a special low calorie diet, or by a structured program of exercise. This will be compared with the usual standard diabetes care. As well as looking to see if the heart's function can be improved with the intervention, we also aim to identify what the mechanism of any improvement would be. We suspect that changes in the amount of fat within the liver and the heart may be responsible, and will measure these at the beginning, end and in some patients halfway through the study to explore possible mechanisms amongst other clinical variables (e.g. HbA1c)

Eligibility

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

Conditions3

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