MenopauseEMPOWERNCT07486986
Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health
An observational study of Menopause and Sleep Disruption, run by Ottawa Heart Institute Research Corporation.
Trial summary
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 48 to 58 years, women only
- Conditions the study is for
- Menopause, Sleep Disruption, T2DM
- What is being tested?
- 4 years of clinical evaluations.
- How many people
- 381 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 58 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
Read the 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.
- Conditions
- Menopause, Sleep Disruption, T2DM
- Being tested
- 4 years of clinical evaluations.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 4 years of clinical evaluations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced septal e' velocity
Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography.
Measured: Baseline to 4 years.
Increased E/e' ratio
Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.
Measured: Baseline to 4 years.
Increased tricuspid regurgitation (TR) velocity
Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 4 years.
Secondary outcomes (2)
Decline in left ventricular global longitudinal strain (GLS)
Detects heart muscle dysfunction. Measured by echocardiography.
Measured: 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.
Measured: Baseline to 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 381 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerri Anne Mullen, Ph.D., Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486986
- Sponsor's protocol ID
- 20260060-01H
- Acronym
- EMPOWER
- Status last verified
- Nov 2026
- First submitted
- 17 Mar 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health
- ClinicalTrials.gov ID
- NCT07486986
- Acronym / sponsor ID
- EMPOWER / 20260060-01H
- Conditions
- Menopause, Sleep Disruption, T2DM
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 381 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation | – | Other: 4 years of clinical evaluations.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. |
Who may qualify
- Ages
- 48 to 58 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 years of clinical evaluations.The intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause. | Other | Evaluation |
Primary outcome
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.
Increased E/e' ratio
Time frame: Baseline to 4 years.
Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.
Increased tricuspid regurgitation (TR) velocity
Time frame: Baseline to 4 years.
Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.
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.
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.
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.
2 secondary outcomes
Decline in left ventricular global longitudinal strain (GLS)
Time frame: Baseline to 4 years.
Decline in left atrial strain
Time frame: Baseline to 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kerri Anne Mullen, Ph.D. principal investigator
Ottawa Heart Institute Research Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Sleep Disruption, run by Ottawa Heart Institute Research Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Van Dam (613-696-7000, CVandam@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced septal e' velocity (time frame: Baseline to 4 years.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.