Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age48-58
SponsorOttawa Heart Institute Research Corporation

About this trial

EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female Sex

Age range 48-58 years

In menopausal transition phase (pre-menopause or peri-menopause)

Diagnosis of Type 2 Diabetes Mellitus

Disqualifiers

Male Sex

Currently Pregnant

Prior history of total hysterectomy or bilateral oophorectomy

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 4 years of clinical evaluations.

    Other intervention

    The intervention in this study is the additional clinical evaluations for women with type 2 DM and in perimenopause.

Treatment groups

381 Participants
are divided into 1 treatment group
Group A: Evaluation1 intervention

Trial outcomes

Primary outcomes

1

Reduced septal e' velocity

Indicates impaired relaxation of the left ventricle during early diastole; key marker for diastolic dysfunction. Measured by echocardiography.

Time frame
Baseline to 4 years.
2

Increased E/e' ratio

Indicates elevated left ventricular filling pressure; key marker for diastolic dysfunction. Measured by echocardiography.

Time frame
Baseline to 4 years.
3

Increased tricuspid regurgitation (TR) velocity

Indicates elevated right ventricular systolic pressure or pulmonary hypertension. Measured by echocardiography.

Time frame
Baseline to 4 years.
4

Change in pulmonary artery systolic pressure (PASP)

Measures the pressure in the pulmonary artery when the heart beats. Measured by echocardiography.

Time frame
Baseline to 4 years.

Secondary outcomes

1

Decline in left ventricular global longitudinal strain (GLS)

Detects heart muscle dysfunction. Measured by echocardiography.

Time frame
Baseline to 4 years.
2

Decline in left atrial strain

Indicates left ventricular diastolic dysfunction, heart failure with preserved ejection fraction, and atrial fibrillation. Measured by echocardiography.

Time frame
Baseline to 4 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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