- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00361075
Midlife Cholesterol Study
November 4, 2014 updated by: Northwestern University
Mentored Patient Oriented Research Career Development Award
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment
120
Phase
- Phase 4
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
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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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
47 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
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: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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LDL particle size and density
|
Secondary Outcome Measures
Outcome Measure |
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Lipid Profile
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Adipocytokines
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Total body adiposity (Dexa scans)
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Intra-abdominal fat (CT scans)
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Inflammatory Factors
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Molly C. Carr, MD, Northwestern University
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
- Carr MC, Hokanson JE, Deeb SS, Purnell JQ, Mitchell ES, Brunzell JD. A hepatic lipase gene promoter polymorphism attenuates the increase in hepatic lipase activity with increasing intra-abdominal fat in women. Arterioscler Thromb Vasc Biol. 1999 Nov;19(11):2701-7. doi: 10.1161/01.atv.19.11.2701.
- Carr MC, Kim KH, Zambon A, Mitchell ES, Woods NF, Casazza CP, Purnell JQ, Hokanson JE, Brunzell JD, Schwartz RS. Changes in LDL density across the menopausal transition. J Investig Med. 2000 Jul;48(4):245-50.
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
July 1, 1998
Study Completion (ACTUAL)
May 1, 2005
Study Registration Dates
First Submitted
August 3, 2006
First Submitted That Met QC Criteria
August 3, 2006
First Posted (ESTIMATE)
August 7, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
November 5, 2014
Last Update Submitted That Met QC Criteria
November 4, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5K23RR016067-05 (NIH)
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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