Association of ambulatory blood pressure with coronary microvascular and cardiac dysfunction in asymptomatic type 2 diabetes.
Jian L Yeo, Gaurav S Gulsin, Emer M Brady...
https://pubmed.ncbi.nlm.nih.gov/35643571/Actively Recruiting
Led by University of Leicester · Updated on 2024-01-05
593
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are investigating the prevalence and causes of early heart dysfunction in adults with type 2 diabetes T2D. This observational study focuses on adults aged 18 to 75 years who have stable T2D without symptoms of cardiovascular disease. The goal is to better understand heart changes in diabetes, which could lead to new treatment targets. The study will compare 518 adults with T2D to 75 healthy individuals matched by age, gender, and ethnicity. Participants will undergo a thorough heart evaluation using several imaging techniques, including cardiac MRI with spectroscopy, echocardiography, CT coronary calcium scoring, and manganese-enhanced MRI in some cases. They will also have cardiopulmonary exercise testing, 24-hour blood pressure monitoring, and wear an accelerometer watch for 7 days to track physical activity. Blood samples will be collected to analyze health markers and develop a protein signature related to early heart failure. During the study, researchers will assess heart structure, function, and blood flow, measuring things like left ventricular strain and myocardial steatosis. They will track early signs of heart failure over 5 years and examine how heart function relates to exercise capacity. Safety and health will be monitored through these tests and blood work. The total study duration spans several years with periodic assessments to understand heart changes in people with type 2 diabetes.
CONDITIONS
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
G
Gerry P McCann, MD
G
Gaurav S Gulsin, MBChB(Hons)
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University of Leicester
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day to 1 week
Participants undergo multiple diagnostic tests including cardiovascular magnetic resonance imaging, transthoracic echocardiography, computed tomography coronary artery calcium scoring, cardiopulmonary exercise testing, manganese-enhanced magnetic resonance imaging (for a subset), ambulatory blood pressure monitoring, wearing an accelerometer watch to collect physical activity data, and blood sample collection to assess cardiovascular function and health status.
1 to 2 visits depending on tests performed
Duration - Up to 5 years
Participants are observed over time to monitor the prevalence and determinants of subclinical cardiovascular dysfunction and to track health outcomes related to type 2 diabetes.
Follow-up visits may be scheduled as needed during the study period
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Jian L Yeo, Gaurav S Gulsin, Emer M Brady...
https://pubmed.ncbi.nlm.nih.gov/35643571/Sarah L Ayton, Saadia Aslam, Abhishek Dattani...
https://pubmed.ncbi.nlm.nih.gov/41663151/University of Leicester
Lead Sponsor