Cardiovascular Prophylaxis for Postmenopausal Women

Phase 2UnknownNCT01219725

University of Leeds100 enrolled

Overview

The purpose of this study was to examine the effect of 6 months moderate intensity exercise training completed three times per week upon traditional and emerging cardiovascular disease risk factors in postmenopausal women both with and without type 2 diabetes. These risk factors include blood markers associated with increased risk such as cholesterol, insulin, glucose and markers of inflammation plus measures of body fat, heart and lung fitness, vascular stiffness and vascular function. The study hypothesised that moderate intensity exercise training would intervene in the exaggerated risk seen in women following the menopause, especially in those with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Cardiovascular Disease

Interventions

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy and stable type II diabetic postmenopausal women (cessation of menstrual periods for 12 months and confirmed with LH/FSH samples) aged 45 - 65 years old for the cross sectional analysis and exercise training study. Exclusion Criteria: * Identified abnormalities during baseline testing. * Vigorously active women. * Women who are pregnant. * Women with serious systemic or psychological disorders (e.g. COPD, asthma, clinical depression). * Women with known coronary artery disease. * Women with significant cardiovascular pathologies and associated medication. * Women with type 1 or insulin treated diabetes. * Women with diabetes with complications. * Women with unstable diabetes or hypertension. * Women with any cancer. * Women with musculoskeletal impairments or contraindications to exercise.

Outcomes

Primary Outcomes

Maximal oxygen uptake

Time frame: 6 months

Secondary Outcomes

lipoprotein profile

Time frame: 6 months

Flow mediated dilation

Time frame: 6 months

Cardiac power output

Time frame: 6 months

Arterial stiffness

Time frame: 6 months

Inflammatory markers

Time frame: 6 months

Body composition

Time frame: 6 months

Cardiovascular Prophylaxis for Postmenopausal Women

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts