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Cardiovascular Prophylaxis for Postmenopausal Women

U

University of Leeds

Status and phase

Unknown
Phase 2

Conditions

Cardiovascular Disease

Treatments

Behavioral: Exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT01219725
RG2508/06/08

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Central trial contact

Karen M Birch, BSc, PhD

Data sourced from clinicaltrials.gov

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