Weight loss and exercise to improve heart function in young adults with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.