Perturbation endocrinienne, ménopause et mauvais sommeil chez les femmes atteintes de diabète de type 2 : effets sur la santé cardiovasculaire (EMPOWER)
EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Carolyn Van Dam
- Numéro de téléphone: 613-696-7000
- E-mail: CVandam@ottawaheart.ca
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reduced septal e' velocity
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Decline in left ventricular global longitudinal strain (GLS)
Délai: Baseline to 4 years.
|
Detects heart muscle dysfunction. Measured by echocardiography. |
Baseline to 4 years.
|
|
Decline in left atrial strain
Délai: 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.
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Kerri Anne Mullen, Ph.D., Ottawa Heart Institute Research Corporation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 20260060-01H
Informations sur les médicaments et les dispositifs, documents d'étude
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