Reduction of Triglycerides in Women on Hormone Replacement Therapy

Cardiovascular Diseases Clinical Trial

Official title:

Reduction of Triglycerides in Women on HRT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023543
• Other study ID #: 981
• Secondary ID: R01HL066468-06R0
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2001
• Last updated: June 18, 2013
• Start date: September 2001
• Est. completion date: May 2010

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effect of lifestyle intervention on subclinical cardiovascular disease measures in women taking hormone replacement therapy (HRT).

Description:

BACKGROUND:

Cardiovascular disease is a common cause of morbidity and mortality in older women. Better methods of prevention via health promotion are needed. Estrogen HRT may beneficially affect women's cardiovascular health, based on evidence from observational studies, but recent trial evidence suggests HRT may actually lead to increased risk of cardiovascular disease in new users. Understanding this untoward effect of HRT and how to prevent it is a significant aim.

DESIGN NARRATIVE:

This randomized trial of 500 women on HRT for at least two years, aged 52-60 years, and three or more years postmenopausal will test whether reduction in waist circumference, triglycerides, dense low density lipoprotein cholesterol (LDLc), number of LDL particles, C-reactive protein, and plasminogen activator inhibitor-I (PAI-I) by aggressive diet and exercise, versus a health education control, and will decrease progression or result in regression of measures of subclinical vascular disease. The intervention is designed to reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. The primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels, a 5 cm decrease in waist circumference, and a 10 percent decrease in LDLc. This will result in changes in subclinical measurements, including carotid ultrasound, electron beam computer tomography of the coronary artery and aorta, pulse wave velocity, endothelial function, and tonometry of the radial artery. Nuclear magnetic resonance spectroscopy of lipoproteins, inflammatory markers, and estrogen metabolites will also be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 52 Years to 60 Years

Eligibility

Inclusion Criteria:

• On HRT for at least two years

• Women 52 to 60 years of age

• Three or more years postmenopausal

• Waist circumference greater than 80 cm

• LDLc between 100 and 160 mg/dl

• Body mass index 25-39.9 kg/m2

• Blood Pressure less than 160/95 mm Hg

• Beck Depression Inventory Score less than 20

Exclusion Criteria:

• Current use of cholesterol-lowering medication

• Diagnosis of diabetes

• On diabetes medication

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Heart Diseases
• Postmenopause

Intervention

Behavioral:
• Diet, fat-restricted
Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.
• Exercise
Rigorous, stepped care approach to reach 150 min/week of physical activity.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kuller LH, Kinzel LS, Pettee KK, Kriska AM, Simkin-Silverman LR, Conroy MB, Averbach F, Pappert WS, Johnson BD. Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Act — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of subclinical disease		5 years	No
Primary	Change in coronary calcium (EBCT)		5 years	No
Primary	Change in carotid intima media wall thickness		5 years	No
Primary	Change in vascular stiffness (PWV)		5 years	No
Secondary	Change in waist circumference and weight		5 years	No
Secondary	Change in LDL particles, triglycerides and small, medium and large LDL particles		5 years	No
Secondary	Change in HDL particles		5 years	No
Secondary	Change in insulin and glucose		5 years	No
Secondary	Change in systolic blood pressure, diastolic blood pressure		5 years	No