Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction. The Diastolic Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
United Kingdom
Glenfield Hospital (University Hospitals of Leicester NHS Trust)
RECRUITING
Leicester
Contact Information
Primary
Gerry P McCann, MD
Gerry.McCann@uhl-tr.nhs.uk
0116 258
Backup
Emer Brady, PhD
emer.brady@uhl-tr.nhs.uk
0116 258
Time Frame
Start Date: 2015-10-02
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 120
Treatments
No_intervention: Standard Care
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.
Experimental: Total Dietary Replacement
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.
Experimental: Supervised Exercise
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.
Sponsors
Leads: University of Leicester
Collaborators: University Hospitals, Leicester, National Institute for Health Research, United Kingdom

This content was sourced from clinicaltrials.gov

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