Reduction of Triglycerides in Women on Hormone Replacement Therapy

June 18, 2013 updated by: University of Pittsburgh

Reduction of Triglycerides in Women on HRT

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

508

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15261
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

52 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measures of subclinical disease
Time Frame: 5 years
5 years
Change in coronary calcium (EBCT)
Time Frame: 5 years
5 years
Change in carotid intima media wall thickness
Time Frame: 5 years
5 years
Change in vascular stiffness (PWV)
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in waist circumference and weight
Time Frame: 5 years
5 years
Change in LDL particles, triglycerides and small, medium and large LDL particles
Time Frame: 5 years
5 years
Change in HDL particles
Time Frame: 5 years
5 years
Change in insulin and glucose
Time Frame: 5 years
5 years
Change in systolic blood pressure, diastolic blood pressure
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

September 7, 2001

First Submitted That Met QC Criteria

September 6, 2001

First Posted (Estimate)

September 7, 2001

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 981
  • R01HL066468-06 (U.S. NIH Grant/Contract)
  • R01HL066468 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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