Weight loss and exercise to improve heart function in young adults with diabetes
Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction. The Diastolic Study
This study tests if a low-calorie diet and exercise can help young adults with type 2 diabetes improve their heart health compared to regular diabetes care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT02590822 on ClinicalTrials.gov |
What this trial studies
This project investigates how type 2 diabetes affects heart function in young adults and whether weight loss or exercise can reverse heart abnormalities. It involves a 12-week randomized trial comparing a low-calorie diet and structured exercise program against standard diabetes care. Participants will undergo detailed heart scans and assessments to evaluate changes in heart structure and function. The study aims to identify factors contributing to heart dysfunction and determine effective interventions for improving heart health in this population.
Who should consider this trial
Good fit: Ideal candidates are young adults aged 18 to 65 with a diagnosis of type 2 diabetes and a body mass index over 30 kg/m2.
Not a fit: Patients with a long history of diabetes, advanced kidney disease, or those on multiple glucose-lowering therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart health and reduced risk of complications for young adults with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results in reversing diabetes-related heart issues through lifestyle interventions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Capacity to provide informed consent before any trial-related activities * Established T2DM (≥3months) * HbA1c ≤ 9% if on triple therapy or ≤ 10% on diet \& exercise or monotherapy or dual therapy * Current glucose lowering therapy either mono, dual or triple of any combination of metformin, sulphonylurea, DPP-IV inhibitor, GLP-1 therapy or an SGLT2 +/- diet and exercise * Poorly managed diet controlled diabetes (with HbA1c \> 6.5% , not currently taking any glucose lowering therapy, meeting BMI inclusion range) * Body mass index \> 30Kg/m2 or \> 27.5 Kg/m2 (South Asian), * Diagnosis of T2DM before the age of 60 years of age * Age ≥18 and ≤ 65 years Exclusion Criteria: * • Diabetes duration \>12 years * Currently taking more than three glucose lowering therapies * Weight-loss of \>5kg in the preceding 6 months * Stage 4 or 5 chronic kidney disease (eGFR\< 30ml/min/1.73m2), * Current therapy with Insulin, thiazolidinediones, steroids or atypical antipsychotic medication * Untreated thyroid disease * Known macrovascular disease including coronary artery disease, stroke/TIA or peripheral vascular disease * Presence of arrhythmia (including atrial fibrillation, atrial flutter, or 2nd or 3rd degree atrioventricular block) * Known heart failure * Other clinically relevant heart disease * Inability to exercise or undertake a MRP * Absolute contraindication to CMR * Cardiovascular symptoms (angina, limiting dyspnoea during normal physical activity) * Inflammatory condition e.g. Connective tissue disorder, Rheumatoid arthritis
Where this trial is running
Leicester
- Glenfield Hospital (University Hospitals of Leicester NHS Trust) — Leicester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gerry Dr McCann, MD — University of Leicester
- Study coordinator: Gerry P McCann, MD
- Email: Gerry.McCann@uhl-tr.nhs.uk
- Phone: 0116 258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.