ISRCTN ISRCTN88646091
DOI https://doi.org/10.1186/ISRCTN88646091
ClinicalTrials.gov number NCT02590822
Secondary identifying numbers 19757
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Ms Emer Brady
Public

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Study information

Study designRandomised; Interventional; Design type: Prevention, Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDiabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular dysfunction (DIASTOLIC)
Study objectivesThe 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) studiedTopic: Diabetes; Subtopic: Type 2; Disease: Cardiovascular disease
InterventionTransthoracic echo, 2 0 20 mins Cardiac physiologists, Cardiovascular BRU, Glenfield
Intervention typeOther
Primary outcome measureIncrease in circumferential peak early-diastolic strain rate (PEDSR) rate is measured using cardiovascular magnetic resonance imaging (CMR) at 12 weeks.
Secondary outcome measuresNot provided at time of registration
Overall study start date05/11/2015
Completion date31/08/2028

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 120; UK Sample Size: 120; Description: phase 1: 100 patients and 20 controls phase 2: 90 patients
Key inclusion criteriaDiabetic 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 criteriaDiabetic 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 enrolment05/11/2015
Date of final enrolment31/08/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

Sponsor information

University of Leicester
University/education

Dept of Health Sciences (General Practice)
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

ROR logo "ROR" https://ror.org/04h699437

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications preliminary study 01/07/2018 10/04/2019 Yes No
Protocol article protocol 30/03/2019 10/04/2019 Yes No
HRA research summary 28/06/2023 No No

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.