Plain English Summary
Background and study aims
Obesity is a medical term used to describe someone who is very overweight. It is generally caused by eating too much and doing too little exercise. Being obese can lead to a number of serious and potentially life-changing medical conditions. Type 2 diabetes mellitus (T2DM) is a growing problem worldwide. People with T2DM have difficulty controlling their blood sugar (glucose) as they do not produce enough insulin to function properly (insulin deficiency), or their body’s cells don’t react to insulin as they should do (insulin resistance). Studies have shown that adults who are suffering from T2DM are more vulnerable to developing problems with their heart and blood vessels (cardiovascular disease), although the reasons for this are not fully understood. This project aims to discover exactly how T2DM causes changes in the heart in young people with T2DM. 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.
Who can participate?
Obese adults who are suffering from T2DM, and obese adults who are in good general health.
What does the study involve?
Participants are randomly allocated to one of three groups. The first group are provided with standard lifestyle advice and contacted weekly to encourage compliance to diet and exercise. The second group are provided with a total meal replacement diet along with health behaviour coaching and relapse prevention through weekly contact with a dietician. The third group attend thrice weekly 60-minute supervised exercise sessions. All participants undergo detailed scans and other tests of the heart’s structure and function.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Leicester Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
November 2015 to August 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Emer Brady
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02590822
Protocol/serial number
19757
Study information
Scientific title
Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular dysfunction (DIASTOLIC)
Acronym
Study hypothesis
The aim of this study is to:
1. Discover exactly 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
2. Find out 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
Ethics approval
West Midlands - Coventry & Warwickshire Research Ethics Committee, 01/07/2015, ref: 15/WM/0222
Study design
Randomised; Interventional; Design type: Prevention, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Diabetes; Subtopic: Type 2; Disease: Cardiovascular disease
Intervention
Transthoracic echo, 2 0 20 mins Cardiac physiologists, Cardiovascular BRU, Glenfield
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
Increase in circumferential peak early-diastolic strain rate (PEDSR) rate is measured using cardiovascular magnetic resonance imaging (CMR) at 12 weeks.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
05/11/2015
Overall trial end date
31/08/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Diabetic patient inclusion criteria:
1. Aged between 18 and 60 years
2. Capacity to provide informed consent before any trial related activities
3. Established T2DM for at least 3 months
4. HbA1c = 9% if on triple therapy or = 10% on diet & exercise or monotherapy or dual therapy
5. Current glucose lowering therapy either mono, dual or triple of any combination of metformin, sulphonylurea, DPPIV inhibitor, GLP1 therapy or an SGLT2 +/- diet and exercise
6. Body mass index > 30Kg/m2 (white Europeans) or > 27Kg/m2 (South East Asian or Afro-Caribbean)
7. Diagnosis of T2DM before the age of 50 years of age
Healthy controls inclusion criteria:
1. Aged between 18 and 60 years
2. Capacity to provide informed consent before any trial related activities
3. Body mass index < 30Kg/m2 (white Europeans) or < 27Kg/m2 (South East Asian or Afro-Caribbean)
4. No cardiovascular symptoms (angina, limiting dyspnoea)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 120; UK Sample Size: 120; Description: phase 1: 100 patients and 20 controls phase 2: 90 patients
Participant exclusion criteria
Diabetic patient exclusion criteria:
1. Aged under 18 or over 60
2. HbA1c >10%
3. Diabetes duration >12 years
4. Currently taking more than three glucose lowering therapies
5. Weight-loss of >5kg in the preceding 6 months
6. Stage 4 or 5 chronic kidney disease (eGFR <30ml/min/1.73m2)
7. Current therapy with insulin, thiazolidinediones (or within the preceeding three months), steroids or atypical antipsychotic medication, untreated thyroid disease
8. Known ischaemic heart disease or heart failure
9. Inability to exercise or undertake a TDR
10. Absolute contraindication to CMR
11. Cardiovascular symptoms (angina, limiting dyspnoea).
12. Patients with asthma will be assessed for suitability of adenosine stress. If adenosine is contraindicated (severe asthma) subjects can participate without perfusion assessment
13. Inflammatory condition e.g. connective tissue disorder, rhematoid arthritis.
Healthy controls inclusion criteria:
1. Aged under 18 or over 60
2. Diabetes or impaired glucose tolerance
3. Obesity (BMI >30 (white european) or >27 (Asian or Afro-Caribbean)
4. Severe asthma
5. History of hypertension, or blood pressure in excess of either 160mmHG systolic or 100mmHG diastolic and currently untreated
6. Inflammatory condition e.g. connective tissue disorder, rheumatoid arthritis
7. Congenital heart disease
8. Renal impairment (eGFR <60ml/min/m2)
9. Other conditions that in the opinion of the investigators may limit exercise capacity or be associated with subclinical cardiac dysfunction
10. Competitive athletes
Recruitment start date
05/11/2015
Recruitment end date
31/08/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2018 preliminary study in: https://www.ncbi.nlm.nih.gov/pubmed/29661781 (added 10/04/2019)
2. 2019 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30928925 (added 10/04/2019)