The DIASTOLIC Study

Phase 4

• Conditions: Topic: Diabetes; Subtopic: Type 2; Disease: Cardiovascular disease; Circulatory System; Cardiovascular disease

• Registration Number: ISRCTN88646091
• Lead Sponsor: niversity of Leicester

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-25
• Last Update Posted: 2 September 2019
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in circumferential peak early-diastolic strain rate (PEDSR) rate is measured using cardiovascular magnetic resonance imaging (CMR) at 12 weeks.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration