DIASTOLIC
Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular dysfunction: The DIASTOLIC Study
There is an epidemic of Type 2 Diabetes Mellitus (T2DM) in younger adults. These patients are at very high life-time risk of cardiovascular disease complications, and diastolic dysfunction is an early manifestation of diabetic cardiomyopathy which predisposes these patients to heart failure and ultimately premature death.
Traditionally T2DM has been regarded as a chronic condition capable of being managed but not cured. There tends to be a steady decline in glycaemic control with the majority of patients ultimately requiring management with insulin or combinations of other glucose-lowering therapy drugs. However proof that T2DM is a reversible condition has been firmly established in patients undergoing bariatric surgery. The extent of weight loss is strongly linked to reversal of T2DM, as is good glycaemic control before surgery. Physical activity has however been shown to be an effective therapy for promoting metabolic health and glucose regulation independent of body weight. However these reports have not assessed sufficiently whether there is any reversal of the damaging effects of T2DM on cardiovascular function with either exercise or dietary weight loss.
The DIASTOLIC study is a 12 week ‘Proof of Concept’, Phase II, randomised study comparing 3 arms: an MRP low energy diet and an exercise programme compared with standard care in young adults with Type II Diabetes Mellitus. The aims of the study are to identify features of diastolic dysfunction (heart problems) assessed by an MRI scan, and determine whether this can be improved by either the diet or the exercise programmes. The study will also recruit a number of healthy volunteers to act as a reference range for the values obtained in the patients undergoing one of the treatment arms.
Phase I: Baseline cross-sectional analysis Will involve a sample of 100 participants and include multivariate analysis of a baseline dataset.
Phase II: Prospective, Randomised, Open label, Blinded End point (PROBE) trial Will involve a randomised sample of 90 participants two one of the three study arms (two primary comparisons MRP vs standard care and exercise vs standard care) to determine diastolic strain rate.
Patients will be recruited to the study either through primary or secondary care invitations sent out to eligible participants, or via a process of patient self-referral in response to advertisements and direct marketing. Patients need to be aged 18-65 years of age, overweight (BMI >30) and to have been diagnosed with Type 2 diabetes, for which they are currently receiving medicated treatment that does not include insulin.
Cambridge Weight Plan® are collaborators with this study and will provide all the meal replacements.
The study has been funded as part of an NIHR Fellowship Awarded to Prof Gerry McCann.