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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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: 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: t
View:

• Participant is willing and able to give informed consent for participation in the study.

• Male or Female, aged ≥18 and ≤75 years.

• Diagnosed with Stable type 2 diabetes (determined by: i) formal diagnosis in GP case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).

Locations
Other Locations
United Kingdom
University of Leicester
RECRUITING
Leicester
Contact Information
Primary
Gerry P McCann, MD
gpm12@le.ac.uk
01162583402
Backup
Gaurav S Gulsin, MBChB(Hons)
gg149@leicester.ac.uk
01162583244
Time Frame
Start Date: 2017-10-24
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 593
Treatments
Type 2 diabetics
Participants will be aged (≥18 and ≤75 years) with T2D and no prior history of cardiovascular disease.
Healthy controls
Cases will be compared with age-, gender- and ethnicity-matched healthy controls.
Sponsors
Leads: University of Leicester

This content was sourced from clinicaltrials.gov