The DIASTOLIC Study
| ISRCTN | ISRCTN88646091 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88646091 |
| ClinicalTrials.gov (NCT) | NCT02590822 |
| Protocol serial number | 19757 |
| Sponsor | University of Leicester |
| Funder | National Institute for Health Research |
- Submission date
- 25/11/2015
- Registration date
- 25/11/2015
- Last edited
- 09/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Public
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Prevention, Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular dysfunction (DIASTOLIC) |
| Study objectives | 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(s) | West Midlands - Coventry & Warwickshire Research Ethics Committee, 01/07/2015, ref: 15/WM/0222 |
| Health condition(s) or problem(s) studied | Topic: Diabetes; Subtopic: Type 2; Disease: Cardiovascular disease |
| Intervention | Transthoracic echo, 2 0 20 mins Cardiac physiologists, Cardiovascular BRU, Glenfield |
| Intervention type | Other |
| Primary outcome measure(s) |
Increase in circumferential peak early-diastolic strain rate (PEDSR) rate is measured using cardiovascular magnetic resonance imaging (CMR) at 12 weeks. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 05/11/2015 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Leicester
LE1 5WW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/03/2019 | 10/04/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | preliminary study | 01/07/2018 | 10/04/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/08/2019: The overall trial end date was changed from 31/08/2018 to 31/08/2028.
10/04/2019: Publication reference added.
14/06/2016: Plain English summary added.
