Reduction of Triglycerides in Women on Hormone Replacement Therapy

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00023543

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

508

Enrollment

Location

Arm

104

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Atherosclerosis Postmenopause Heart Diseases	Behavioral: Diet, fat-restricted Behavioral: Exercise	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

508 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Reduction of Triglycerides in Women on HRT

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

May 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Participants will 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.	Behavioral: Diet, fat-restricted Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods. Behavioral: Exercise Rigorous, stepped care approach to reach 150 min/week of physical activity.

Arm

Intervention/Treatment

Experimental: 1

Participants will 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.

Behavioral: Diet, fat-restricted

Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.

Behavioral: Exercise

Rigorous, stepped care approach to reach 150 min/week of physical activity.

Outcome Measures

Primary Outcome Measures

Measures of subclinical disease [5 years]
Change in coronary calcium (EBCT) [5 years]
Change in carotid intima media wall thickness [5 years]
Change in vascular stiffness (PWV) [5 years]

Secondary Outcome Measures

Change in waist circumference and weight [5 years]
Change in LDL particles, triglycerides and small, medium and large LDL particles [5 years]
Change in HDL particles [5 years]
Change in insulin and glucose [5 years]
Change in systolic blood pressure, diastolic blood pressure [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

52 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261

Sponsors and Collaborators

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

Investigators

Study Chair: Lewis H. Kuller, MD, DPH, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00023543

Other Study ID Numbers:

981
R01HL066468-06
R01HL066468

First Posted:

Sep 7, 2001

Last Update Posted:

Jun 19, 2013

Last Verified:

Jun 1, 2013

Additional relevant MeSH terms:

Cardiovascular Diseases

Heart Diseases

Atherosclerosis

Study Results

No Results Posted as of Jun 19, 2013