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Reduction of Triglycerides in Women on Hormone Replacement Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00023543
First received: September 7, 2001
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Cardiovascular Diseases
Atherosclerosis
Postmenopause
Heart Diseases
Behavioral: Diet, fat-restricted
Behavioral: Exercise
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reduction of Triglycerides in Women on HRT

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Measures of subclinical disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in coronary calcium (EBCT) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in carotid intima media wall thickness [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in vascular stiffness (PWV) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in waist circumference and weight [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in LDL particles, triglycerides and small, medium and large LDL particles [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in HDL particles [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in insulin and glucose [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Change in systolic blood pressure, diastolic blood pressure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 508
Study Start Date: September 2001
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   52 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023543

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Chair: Lewis H. Kuller, MD, DPH University of Pittsburgh
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00023543     History of Changes
Other Study ID Numbers: 981, R01HL066468-06, R01 HL66468
Study First Received: September 7, 2001
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014