4 years of clinical evaluations.
OtherThe intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause.
NCT Number: NCT07486986
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
Trial opening soon.
Get Notified48 year–58 year
Female
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
The intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause.
Time frame: Baseline to 4 years.
Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography.
Time frame: Baseline to 4 years.
Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.
Time frame: Baseline to 4 years.
Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.
Time frame: Baseline to 4 years.
Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography.
Time frame: Baseline to 4 years.
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.
Time frame: Baseline to 4 years.
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.
Time frame: Baseline to 4 years.
Detects heart muscle dysfunction. Measured by echocardiography.
Time frame: Baseline to 4 years.
Indicates left ventricular diastolic dysfunction, heart failure with preserved ejection fraction, and atrial fibrillation. Measured by echocardiography.
Contact information is provided by the study sponsor or research team.
Ottawa Heart Institute Research Corporation
Other
Acronym: EMPOWER
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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