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Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction
Sponsor: University of Leicester
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)
Official title: Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction. The Diastolic Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2015-10-02
Completion Date
2028-08-31
Last Updated
2024-01-05
Healthy Volunteers
Yes
Conditions
Interventions
Cambridge Weight Plan
Group receives a total meal replacement diet from Cambridge Weight Plan containing 810 kcal/day (40% protein, 50% carbohydrate, 10% fat). As 3 or 4 mini-meals daily in flavoured formula food packets made up with water, milk or non-dairy alternative; or as snack bars based on preference. Supplemented with up to three portions of non-starchy vegetables and 2 litres of water, or other non-calorific drinks, per day. Participants to abstain from alcohol for study duration. 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 through weekly, where possible, contact (telephone or face-to-face) with a qualified dietician or equivalent. Due to the potential risk of hypoglycaemia and symptomatic hypotension; medication at enrolment will need to be adjusted initially and throughout the study.
Supervised Exercise Sessions
The exercise group will attend supervised exercise sessions at the Leicester-Loughborough Diet, Lifestyle and Physical Activity (LLP) BRU or at the Leicester Diabetes Centre. The exercise program will typically consist of a thrice weekly, 60 minute session of moderate intensity aerobic exercise, in line with prevailing guidelines. An initial assessment of cardiorespiratory fitness will be performed, and exercise intensity titrated to aim for a workload of approximately 60% of the patient's VO2 max. Due to the potential risk of hypoglycaemia and symptomatic hypotension; medication at enrolment will need to be adjusted initially and throughout the study.
Locations (1)
Glenfield Hospital (University Hospitals of Leicester NHS Trust)
Leicester, United Kingdom