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Contact Information:

Gerry P McCann, MD 01162583402
gpm12@le.ac.uk


Gaurav S Gulsin, MBChB(Hons) 01162583244
gg149@leicester.ac.uk


Study Location:

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Be Part of Research - Trial Details - Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus

Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus

Recruiting

Open to: ALL

Age: 50.0 - 75.0

Medical Conditions

Cardiomyopathies
Diabetic Cardiomyopathies
Diabetes Mellitus
Diabetes Mellitus, Type 2


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood.

Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction in adults with type 2 diabetes (T2D).

Plan: 518 asymptomatic adults (aged 18-75 years) with T2D will undergo comprehensive evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy, echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling. 75 controls will undergo the same evaluation.

Primary hypothesis: myocardial steatosis is an independent predictor of left ventricular global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac dysfunction is related to peak oxygen consumption.

Expected value of results: This study will reveal the prevalence and determinants of cardiac dysfunction in T2D, and could provide targets for novel therapies.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2017 Oct 2029

Publications

"Yeo JL, Gulsin GS, Brady EM, Dattani A, Bilak JM, Marsh AM, Sian M, Athithan L, Parke KS, Wormleighton J, Graham-Brown MPM, Singh A, Arnold JR, Lawson C, Davies MJ, Xue H, Kellman P, McCann GP. Association of ambulatory blood pressure with coronary microvascular and cardiac dysfunction in asymptomatic type 2 diabetes. Cardiovasc Diabetol. 2022 May 28;21(1):85. doi: 10.1186/s12933-022-01528-2."; "35643571"

OBSERVATIONAL

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : CMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum. DIXON technique for the quantification of visceral adiposity and subcutaneous adipose tissue.

Intervention Arm Group : Healthy controls;Type 2 diabetics;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function.

Intervention Arm Group : Healthy controls;Type 2 diabetics;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Computed Tomography coronary calcium scoring to assess the presence of subclinical atherosclerosis and allow an estimate of atheroma burden in addition to epicardial adipose tissue characterisation and systolic strain.

Intervention Arm Group : Healthy controls;Type 2 diabetics;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Physician supervised incremental symptom limited cardiopulmonary exercise tolerance test with ECG and haemodynamic monitoring.

Intervention Arm Group : Healthy controls;Type 2 diabetics;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : A subset of the participants will have cardiac MRI scanning with manganese-based contrast agent, lasting approximately 45-50 minutes. After localisers, baseline functions and native T1 maps have been acquired, Mangafodipir (0.1mL/kg) will be administered intravenously at 1ml/min, with additional T1 maps acquired every 2.5 min after administration of the contrast agent for up to 30 minutes.

Intervention Arm Group : Healthy controls;Type 2 diabetics;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : A 24-hour blood pressure monitor will be worn at the end of the visit to the following day.

Intervention Arm Group : Healthy controls;Type 2 diabetics;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Watch worn to collect free living physical activity data for 7 days.

Intervention Arm Group : Healthy controls;Type 2 diabetics;

Intervention Type : DIAGNOSTIC_TEST
Intervention Description : Collection of blood samples from each participant to characterise the participant's health status and to develop a proteomic signature of early heart failure.

Intervention Arm Group : Healthy controls;Type 2 diabetics;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of Leicester
    Leicester

Gaurav S Gulsin, MBChB(Hons) 01162583244
gg149@leicester.ac.uk


Gerry P McCann, MD 01162583402
gpm12@le.ac.uk



The study is sponsored by University of Leicester




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Read full details for Trial ID: NCT03132129
Last updated 03 January 2024

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