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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Sleep Disruption; T2DM
• Intervention / Treatment: Other: 4 years of clinical evaluations.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 381

Contacts and Locations

• Study Contact: Name: Carolyn Van Dam; Phone Number: 613-696-7000; Email: CVandam@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 4 years of clinical evaluations.; The intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	Baseline to 4 years.

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Kerri Anne Mullen, Ph.D., Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20260060-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No