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NCT Number: NCT07486986

Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health

EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.

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Key information

Age range

48 year–58 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female Sex
  • Age range 48-58 years
  • In menopausal transition phase (pre-menopause or peri-menopause)
  • Diagnosis of Type 2 Diabetes Mellitus
  • Have access to and regularly use a smartphone with internet access

Exclusion criteria

  • Male Sex
  • Currently Pregnant
  • Prior history of total hysterectomy or bilateral oophorectomy
  • Prior diagnosis of any of the following:

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).

Treatment and study plan

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.

Primary outcomes

  1. Reduced septal e' velocity

    Time frame: Baseline to 4 years.

    Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography.

  2. Increased E/e' ratio

    Time frame: Baseline to 4 years.

    Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.

  3. Increased tricuspid regurgitation (TR) velocity

    Time frame: Baseline to 4 years.

    Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.

  4. Change in pulmonary artery systolic pressure (PASP)

    Time frame: Baseline to 4 years.

    Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography.

  5. Change in E/A ratio

    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.

  6. Change in left atrial size

    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.

Secondary outcomes

  1. Decline in left ventricular global longitudinal strain (GLS)

    Time frame: Baseline to 4 years.

    Detects heart muscle dysfunction. Measured by echocardiography.

  2. Decline in left atrial strain

    Time frame: Baseline to 4 years.

    Indicates left ventricular diastolic dysfunction, heart failure with preserved ejection fraction, and atrial fibrillation. Measured by echocardiography.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Van Dam

CONTACT

[email protected]

613-696-7000

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Acronym: EMPOWER

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Mar 23, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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