Trials / Not Yet Recruiting
Not Yet RecruitingNCT07486986
Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 381 (estimated)
- Sponsor
- Ottawa Heart Institute Research Corporation · Academic / Other
- Sex
- Female
- Age
- 48 Years – 58 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2032-12-01
- Completion
- 2032-12-01
- First posted
- 2026-03-23
- Last updated
- 2026-03-23
Source: ClinicalTrials.gov record NCT07486986. Inclusion in this directory is not an endorsement.