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Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction

RecruitingNAAges 18 Years - 65 YearsAllUniversity of Leicester
NCT02590822 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

There is an epidemic of type 2 diabetes in younger adults. These patients are at very high lifetime risk of heart-related complications. Subtle heart abnormalities can be present even at a young age in these patients and may predispose them to heart failure and ultimately premature death. There is emerging evidence that type 2 diabetes can be reversed with weight loss. We propose that weight loss can also reverse the fatty changes seen in the liver and heart in these patients, and in turn lead to improved heart function. This project aims to identify 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. 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 progr

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📋 Eligibility rules (as published)
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
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What it tests

  • Cambridge Weight Plan
  • Supervised Exercise Sessions
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Where

1 site
Glenfield Hospital (University Hospitals of Leicester NHS Trust)
Leicester, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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