Cardiovascular Prophylaxis for Postmenopausal Women

Phase 2

• Conditions: Cardiovascular Disease

• Registration Number: NCT01219725
• Lead Sponsor: University of Leeds

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-07
• Status Verified: 2009-05
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Last Update Submitted: 2010-10-27
• Last Update Posted: 2010-10-28
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximal oxygen uptake	6 months

Secondary Outcome Measures

Name	Time	Method
lipoprotein profile	6 months
Flow mediated dilation	6 months
Cardiac power output	6 months
Arterial stiffness	6 months
Inflammatory markers	6 months
Body composition	6 months

Trial Locations

Locations (1)

Centre for Sports and Exercise Sciences, University of Leeds; 🇬🇧 Leeds, West Yorkshire, United Kingdom