Condition category
Circulatory System
Date applied
25/11/2015
Date assigned
25/11/2015
Last edited
14/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Ms Emer Brady

ORCID ID

Contact details

Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
United Kingdom

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 measures

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

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

Sponsor information

Organisation

University of Leicester

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/06/2016: Plain English summary added.