Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiov… (NCT07486986) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health
381 participantsStarted 2026-09
Plain-language summary
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
Who can participate
Age range
48 Years – 58 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at how menopause and poor sleep together might affect heart function in women with type 2 diabetes — specifically things like heart filling pressures and the size of the left atrium. Given my situation with diabetes and where I am in my menopause journey, does my doctor think these are risks I should already be paying attention to, whether or not I join a study like this?
2The trial hasn't started recruiting yet — so what does my doctor think about the realistic timeline before I could even participate, and is there anything I should be doing right now to protect my heart health while I wait to see if this becomes an option?
3Since this study is observational and measuring outcomes like E/e' ratio and left atrial size, it sounds like it may involve echocardiograms and possibly sleep monitoring — can my doctor help me understand what kinds of tests or time commitments a study like this would typically involve, and whether that fits my current schedule and health?
4The trial is specifically focused on women with type 2 diabetes who are going through menopause and have sleep disruption — how does my doctor assess whether my own sleep problems are significant enough to be relevant here, and should I be getting evaluated for something like sleep apnea regardless of this trial?
5Are there already established treatments or monitoring approaches my doctor recommends for the heart risks tied to menopause and poor sleep in type 2 diabetes, and how would participating in an observational study like this fit alongside — or potentially delay — getting that kind of care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduced septal e' velocity
Timeframe: Baseline to 4 years.
2
Increased E/e' ratio
Timeframe: Baseline to 4 years.
3
Increased tricuspid regurgitation (TR) velocity
Timeframe: Baseline to 4 years.
4
Change in pulmonary artery systolic pressure (PASP)
Timeframe: Baseline to 4 years.
5
Change in E/A ratio
Timeframe: Baseline to 4 years.
6
Change in left atrial size
Timeframe: Baseline to 4 years.
Trial details
NCT IDNCT07486986
SponsorOttawa Heart Institute Research Corporation