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EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
The EMPOWER prospective cohort study is part of a larger project. This interdisciplinary project will utilize animal models, clinical cohorts, epidemiological datasets and data from randomized control trials to explore the hypothesis that sleep disruption and menopause-induced hormonal changes synergistically increase systemic inflammation and impair incretin signaling, leading to worsened cardiac function, heightened cardiometabolic dysfunction, and accelerated CVD risk.
The EMPOWER study aims to determine the cumulative effect of multiple exposures including menopause progression and sleep disruption on subclinical cardiac remodeling in women with T2DM in the perimenopausal transition and if these relationships are moderated by T2DM management, Body Mass Index (BMI), or inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation | This is a non-randomized study following individuals in perimenopause with type 2 diabetes. The population will follow a 4 evaluation/observation period with associated questionnaires and medical exams, including bloodwork and cardiac echo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 years of clinical evaluations. | Other | The intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause. |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduced septal e' velocity | Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography. | Baseline to 4 years. |
| Increased E/e' ratio | Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography. | Baseline to 4 years. |
| Increased tricuspid regurgitation (TR) velocity | Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography. | Baseline to 4 years. |
| Change in pulmonary artery systolic pressure (PASP) | Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography. | Baseline to 4 years. |
| Change in E/A ratio | Decrease of E/A ratio below 1 indicates diastolic dysfunction, and an increase of E/A ratio over 2 indicates advance failure. Measured by echocardiography. | Baseline to 4 years. |
| Change in left atrial size | Left Atrial Enlargement (LAE) is abnormal stretching or widening of the upper left heart chamber, typically caused by chronic pressure or volume overload. Measured by echocardiography. | Baseline to 4 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Decline in left ventricular global longitudinal strain (GLS) | Detects heart muscle dysfunction. Measured by echocardiography. | Baseline to 4 years. |
| Decline in left atrial strain | Indicates left ventricular diastolic dysfunction, heart failure with preserved ejection fraction, and atrial fibrillation. Measured by echocardiography. |
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Inclusion Criteria:
Exclusion Criteria:
Coronary Vascular Disease (CVD) including coronary heart disease, heart failure, congenital heart disease stroke/transient ischemic attack, valvular heart disease, peripheral vascular disease, aortapathy, atrial fibrillation or flutter, other CVD.
- Untreated serious mental illness (e.g, untreated psychosis).
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Van Dam | Contact | 613-696-7000 | CVandam@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kerri Anne Mullen, Ph.D. | Ottawa Heart Institute Research Corporation | Principal Investigator |
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| Baseline to 4 years. |