Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 4 years of clinical evaluations..
- Who it may be relevant to
- Registry conditions: Menopause, Sleep Disruption, T2DM. Basic parameters: 48 years — 58 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Reduced septal e' velocity [Time frame: Baseline to 4 years.]
- Increased E/e' ratio [Time frame: Baseline to 4 years.]
- Increased tricuspid regurgitation (TR) velocity [Time frame: Baseline to 4 years.]
- Change in pulmonary artery systolic pressure (PASP) [Time frame: Baseline to 4 years.]
- Change in E/A ratio [Time frame: Baseline to 4 years.]
- Change in left atrial size [Time frame: Baseline to 4 years.]
Secondary outcome measures (2)
- 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.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07486986 · 20260060-01H