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

September 7, 2001
June 18, 2013
September 2001
May 2010   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00023543 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Reduction of Triglycerides in Women on Hormone Replacement Therapy
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).

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Atherosclerosis
  • Postmenopause
  • Heart Diseases
  • 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.
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.
Interventions:
  • Behavioral: Diet, fat-restricted
  • Behavioral: Exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
508
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
52 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00023543
981, R01HL066468-06, R01 HL66468
Not Provided
University of Pittsburgh
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Lewis H. Kuller, MD, DPH University of Pittsburgh
University of Pittsburgh
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP