Actively Recruiting
Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction
Led by University of Leicester · Updated on 2024-01-05
120
Participants Needed
1
Research Sites
673 weeks
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
U
University Hospitals, Leicester
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Diabetes Interventional Assessment of Slimming or Training to Lessen Inconspicuous Cardiovascular Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent before any trial activities
- Diagnosis of type 2 diabetes for at least 3 months
- HbA1c of 9% or less if on triple therapy, or 10% or less if on diet and exercise, monotherapy, or dual therapy
- Currently on one to three glucose lowering therapies including metformin, sulphonylurea, DPP-IV inhibitor, GLP-1 therapy, or SGLT2, with or without diet and exercise
- Poorly managed diet-controlled diabetes with HbA1c above 6.5% and not currently on glucose lowering therapy, meeting BMI criteria
- Body mass index over 30 kg/m2 or over 27.5 kg/m2 for South Asian participants
- Diagnosed with type 2 diabetes before age 60
- Age between 18 and 65 years
You will not qualify if you...
- Diabetes duration longer than 12 years
- Taking more than three glucose lowering therapies
- Weight loss greater than 5 kg in the past 6 months
- Stage 4 or 5 chronic kidney disease (eGFR less than 30 ml/min/1.73m2)
- Current treatment with insulin, thiazolidinediones, steroids, or atypical antipsychotic medication
- Untreated thyroid disease
- Known macrovascular disease such as coronary artery disease, stroke/TIA, or peripheral vascular disease
- Presence of arrhythmia including atrial fibrillation, atrial flutter, or advanced atrioventricular block
- Known heart failure or other clinically significant heart disease
- Inability to exercise or undergo magnetic resonance procedures
- Absolute contraindication to cardiac MRI
- Cardiovascular symptoms like angina or limiting shortness of breath during normal activity
- Inflammatory conditions such as connective tissue disorders or rheumatoid arthritis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Glenfield Hospital (University Hospitals of Leicester NHS Trust)
Leicester, United Kingdom, LE3 9QP
Actively Recruiting
Research Team
G
Gerry P McCann, MD
CONTACT
E
Emer Brady, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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