内分泌攪乱、閉経、および2型糖尿病女性における不眠：心血管健康への影響 (EMPOWER)
内分泌攪乱、閉経、および2型糖尿病女性における睡眠障害：心血管健康への影響
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Carolyn Van Dam
- 電話番号：613-696-7000
- メール：CVandam@ottawaheart.ca
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
The intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Reduced septal e' velocity
時間枠：Baseline to 4 years.
|
Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography. |
Baseline to 4 years.
|
|
Increased E/e' ratio
時間枠：Baseline to 4 years.
|
Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography. |
Baseline to 4 years.
|
|
Increased tricuspid regurgitation (TR) velocity
時間枠：Baseline to 4 years.
|
Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography. |
Baseline to 4 years.
|
|
Change in pulmonary artery systolic pressure (PASP)
時間枠：Baseline to 4 years.
|
Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography. |
Baseline to 4 years.
|
|
Change in E/A ratio
時間枠：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. |
Baseline to 4 years.
|
|
Change in left atrial size
時間枠：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. |
Baseline to 4 years.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Decline in left ventricular global longitudinal strain (GLS)
時間枠：Baseline to 4 years.
|
Detects heart muscle dysfunction. Measured by echocardiography. |
Baseline to 4 years.
|
|
Decline in left atrial strain
時間枠：Baseline to 4 years.
|
Indicates left ventricular diastolic dysfunction, heart failure with preserved ejection fraction, and atrial fibrillation. Measured by echocardiography. |
Baseline to 4 years.
|
協力者と研究者
捜査官
- 主任研究者：Kerri Anne Mullen, Ph.D.、Ottawa Heart Institute Research Corporation
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20260060-01H
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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