Midlife Cholesterol Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361075
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : November 5, 2014
University of Washington
Information provided by:
Northwestern University

Brief Summary:
The postmenopausal state is associated with an increase risk for heart disease. Much of this increase in risk may be due to the loss of estrogen (the main female hormone) and the effect of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid levels. The purpose of this research study is to understand 1) how menopause affects lipids and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.

Condition or disease Intervention/treatment Phase
Menopause Postmenopause Premenopause Cardiovascular Disease Drug: transdermal estradiol patch (Vivelle), oral estrogen (Estrace), progesterone (Prometrium) Phase 4

Detailed Description:
Women with the Metabolic Syndrome (central obesity, insulin resistance, and dyslipidemia) are at especially high risk for coronary heart disease (CHD). The prevalence of the Metabolic Syndrome increases with menopause and may partially explain the acceleration in CHD after menopause. Menopause is associated with increased central adiposity, insulin resistance, dyslipidemia (hypertriglyceridemia, increased low density lipoprotein (LDL), reduced high density lipoprotein (HDL) and small dense LDL particles), and increased thrombotic/inflammatory states, but there are no studies investigating the mechanisms that mediate these changes. The objectives of the proposed project are to investigate the emergence of the features of the Metabolic Syndrome in women followed prospectively through the menopause and determine if these features can be reversed with transdermal estrogen. We hypothesize that the increase in central adiposity with menopause will be a major contributor to the increased prevalence of the Metabolic Syndrome with menopause. This is the first prospective study to investigate the 1) effects of menopause and 2) estrogen replacement therapy (ERT) (oral vs. transdermal) on features of the Metabolic Syndrome. We will determine if the increase in central (intraabdominal)fat with menopause is associated with changes in lipids, insulin resistance, adipocytokines, and fibrinolytic/inflammatory markers. We will then determine if these changes can be reversed with transdermal ERT, as compared to oral ERT, which has pharmacologic effects on the liver.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mentored Patient Oriented Research Career Development Award
Study Start Date : July 1998
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Primary Outcome Measures :
  1. LDL particle size and density

Secondary Outcome Measures :
  1. Total body adiposity (Dexa scans)
  2. Intra-abdominal fat (CT scans)
  3. Lipid Profile
  4. Inflammatory Factors
  5. Adipocytokines

Information from the National Library of Medicine

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Ages Eligible for Study:   47 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Have demonstrated an interest to participate in the ERT trial
  • Be premenopausal (have menstrual period in previous three months) prior to start of observational arm
  • Prior to start of interventional arm (ERT), the women must be postmenopausal (have not had a menstrual cycle in the past twelve months and FSH >30)
  • Be between the ages of 47 and 55
  • Not be taking any form of estrogen replacement
  • Have an intact uterus and at least one ovary and normal screening mammogram in the 12 months prior to starting ERT

Exclusion Criteria:

  • Body mass index (kg/m2) greater than 40 kg/m2
  • History of diabetes mellitus or fasting >110 mg/dl at screening
  • Abnormal fasting LDL or triglyceride
  • Use of lipid lowering medications, beta-blockers, birth control pills
  • Active liver disease (recent history of active hepatitis, jaundice, scleral icterus, and/or elevated liver function tests
  • History of breast, endometrial or ovarian cancer
  • History of thrombotic disorder (past history of pulmonary embolus or deep venous thrombosis) or known history of CAD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361075

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Northwestern University
University of Washington
Principal Investigator: Molly C. Carr, MD Northwestern University

Publications: Identifier: NCT00361075     History of Changes
Other Study ID Numbers: 5K23RR016067-05 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Northwestern University:
Abdominal adipose tissue
Women's health
Lipid Metabolism

Additional relevant MeSH terms:
Cardiovascular Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs