Weight Loss or Exercise for Type 2 Diabetes and Heart Health
Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction
Recruiting
N/AInterventional Study
Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
University of Leicester · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes to understand how weight loss or exercise can improve heart function. Participants will follow a low-calorie diet or an exercise program and undergo tests to monitor their heart health.
Are You a Good Fit for This Trial?
Must be takingMetforminSulphonylureaDPP-IV inhibitorGLP-1 therapySGLT2
Rules you outStage 4 chronic kidney diseaseHeart failureMacrovascular disease
You may be able to join if
I am between 18 and 65 years old
I have been diagnosed with type 2 diabetes for at least 3 months
My HbA1c is 9% or less on triple therapy, or 10% or less on diet and exercise or other treatments
I have a body mass index (BMI) over 30 or over 27.5 if I am South Asian
I was diagnosed with type 2 diabetes before age 60
I can provide informed consent
I am currently managing my diabetes with certain glucose-lowering therapies
You may not be able to join if
I have had diabetes for more than 12 years
I take more than three different glucose-lowering medications
I have lost more than 5 kg in the last 6 months
I have stage 4 or 5 chronic kidney disease
I am currently using insulin or certain other medications
I have untreated thyroid disease
I have known heart disease or heart failure
I have significant difficulty exercising
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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 program of exercise. This will be compared with the usual standard diabetes care.
As well as looking to see if the heart's function can be improved with the intervention, we also aim to identify what the mechanism of any improvement would be. We suspect that changes in the amount of fat within the liver and the heart may be responsible, and will measure these at the beginning, end and in some patients halfway through the study to explore possible mechanisms amongst other clinical variables (e.g. HbA1c)
Trial Locations
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Eligibility 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 combinatio…
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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