About this trial
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female Sex
Age range 48-58 years
In menopausal transition phase (pre-menopause or peri-menopause)
Diagnosis of Type 2 Diabetes Mellitus
Disqualifiers
Male Sex
Currently Pregnant
Prior history of total hysterectomy or bilateral oophorectomy
Trial population
The study population will be selected from patients at the University of Ottawa Heart Institute, The Ottawa Hospital, and from within the Ottawa and surrounding area community.
Trial design
Cohort
Prospective
Treatments tested in this trial
4 years of clinical evaluations.
Other interventionThe intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause.
Treatment groups
Trial outcomes
Primary outcomes
Reduced septal e' velocity
Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography.
Increased E/e' ratio
Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.
Increased tricuspid regurgitation (TR) velocity
Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.
Change in pulmonary artery systolic pressure (PASP)
Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography.
Secondary outcomes
Decline in left ventricular global longitudinal strain (GLS)
Detects heart muscle dysfunction. Measured by echocardiography.
Decline in left atrial strain
Indicates left ventricular diastolic dysfunction, heart failure with preserved ejection fraction, and atrial fibrillation. Measured by echocardiography.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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