Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 381
- 主要终点
- Reduced septal e' velocity
研究概览
简要总结
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 48 Years 至 58 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: 4 years of clinical evaluations. (Other)
结局指标
主要结局
Reduced septal e' velocity
时间窗: 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
时间窗: Baseline to 4 years.
Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.
Increased tricuspid regurgitation (TR) velocity
时间窗: Baseline to 4 years.
Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.
Change in pulmonary artery systolic pressure (PASP)
时间窗: Baseline to 4 years.
Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography.
Change in E/A ratio
时间窗: 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
时间窗: 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.
次要结局
- Decline in left ventricular global longitudinal strain (GLS)(Baseline to 4 years.)
- Decline in left atrial strain(Baseline to 4 years.)