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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

Brief Summary:

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: 150 asymptomatic older adults (aged 50-75 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. Fifty 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.


Detailed Summary:
Sponsor: University of Leicester

Current Primary Outcome: Myocardial steatosis [ Time Frame: 3 years ]

Myocardial steatosis as an independent predictor of LV global longitudinal strain


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes [ Time Frame: 3 years ]
    Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes
  • Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes [ Time Frame: 3 years ]
    Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes
  • Independent association of CMR measures with aerobic exercise capacity in type 2 diabetes [ Time Frame: 3 years ]
    Independent association of CMR measures (LV systolic and diastolic strain and strain rates) with aerobic exercise capacity (peak VO2) in type 2 diabetes
  • Differences in LV remodelling (indexed LV mass) between cases and controls [ Time Frame: 3 years ]
    Differences in LV remodelling (indexed LV mass) between cases and controls
  • Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes [ Time Frame: 5 years ]
    Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes
  • Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls. [ Time Frame: 3 years ]
    Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls.
  • Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls [ Time Frame: 3 years ]
    Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls
  • Differences in aerobic exercise capacity (peak V02) between cases and controls [ Time Frame: 3 years ]
    Differences in aerobic exercise capacity (peak V02) between cases and controls
  • Differences in myocardial perfusion reserve between cases and controls [ Time Frame: 3 years ]
    Differences in myocardial perfusion reserve between cases and controls
  • Differences in heart rate variability between cases and controls [ Time Frame: 3 years ]
    Differences in heart rate variability between cases and controls


Original Secondary Outcome: Same as current

Information By: University of Leicester

Dates:
Date Received: April 19, 2017
Date Started: June 2017
Date Completion: June 2022
Last Updated: April 24, 2017
Last Verified: April 2017