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Cardiovascular Prophylaxis for Postmenopausal Women

NCT ID: NCT01219725

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Keywords

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Body composition Endothelial function Lipoprotein profile Inflammatory markers Aerobic capacity Thrombotic markers Arterial stiffness Cardiac function Traditional and emerging cardiovascular disease risk factors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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Exercise training

6 months of moderate intensity exercise training 3 times per week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Leeds

OTHER

Sponsor Role lead

Responsible Party

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University of Leeds

Principal Investigators

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Karen M Birch, BSC, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

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Centre for Sports and Exercise Sciences, University of Leeds

Leeds, West Yorkshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Karen M Birch, BSc, PhD

Role: CONTACT

Phone: 44 11336713

Email: [email protected]

Other Identifiers

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RG2508/06/08

Identifier Type: -

Identifier Source: org_study_id