Cardiovascular DiseasesPhase 2NCT00023543
Reduction of Triglycerides in Women on Hormone Replacement Therapy
A Phase 2 study testing Diet, fat-restricted and Exercise in people with Cardiovascular Diseases and Atherosclerosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 52 to 60 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis, Postmenopause
- What is being tested?
- Diet, fat-restricted and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Current use of cholesterol-lowering medication
- Diagnosis of diabetes
- On diabetes medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: 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).
Read the 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.
- Being tested
- Diet, fat-restricted, Exercise
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet, fat-restrictedBehavioural
Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods.
ExerciseBehavioural
Rigorous, stepped care approach to reach 150 min/week of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Behavioral: Diet, fat-restricted; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of subclinical disease
Measured: 5 years
Change in coronary calcium (EBCT)
Measured: 5 years
Change in carotid intima media wall thickness
Measured: 5 years
Change in vascular stiffness (PWV)
Measured: 5 years
Secondary outcomes (5)
Change in waist circumference and weight
Measured: 5 years
Change in LDL particles, triglycerides and small, medium and large LDL particles
Measured: 5 years
Change in HDL particles
Measured: 5 years
Change in insulin and glucose
Measured: 5 years
Change in systolic blood pressure, diastolic blood pressure
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2001 (estimated)
- Study startSep 2001
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Lewis H. Kuller, MD, DPH, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023543
- Sponsor's protocol ID
- 981
- Other IDs
- R01HL066468-06, R01HL066468
- Status last verified
- Jun 2013
- First submitted
- 7 Sep 2001
- Last updated
- 19 Jun 2013
- Results posted
- No
Publications
Kuller LH, Kinzel LS, Pettee KK, Kriska AM, Simkin-Silverman LR, Conroy MB, Averbach F, Pappert WS, Johnson BD. Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Activity and Nutrition (WOMAN study) clinical trial. J Womens Health (Larchmt). 2006 Oct;15(8):962-74. doi: 10.1089/jwh.2006.15.962.
PubMed 17087620Kuller LH, Pettee Gabriel KK, Kinzel LS, Underwood DA, Conroy MB, Chang Y, Mackey RH, Edmundowicz D, Tyrrell KS, Buhari AM, Kriska AM. The Women on the Move Through Activity and Nutrition (WOMAN) study: final 48-month results. Obesity (Silver Spring). 2012 Mar;20(3):636-43. doi: 10.1038/oby.2011.80. Epub 2011 Apr 14.
PubMed 21494228Gabriel KP, McClain JJ, Schmid KK, Storti KL, High RR, Underwood DA, Kuller LH, Kriska AM. Issues in accelerometer methodology: the role of epoch length on estimates of physical activity and relationships with health outcomes in overweight, post-menopausal women. Int J Behav Nutr Phys Act. 2010 Jun 15;7:53. doi: 10.1186/1479-5868-7-53.
PubMed 20550691
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Triglycerides in Women on HRT
- ClinicalTrials.gov ID
- NCT00023543
- Acronym / sponsor ID
- 981
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2001
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Sep 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Diet, fat-restricted, Behavioral: ExerciseParticipants 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. |
Who may qualify
- Ages
- 52 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Current use of cholesterol-lowering medication
- Diagnosis of diabetes
- On diabetes medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet, fat-restrictedReduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods. | Behavioural | 1 |
| ExerciseRigorous, stepped care approach to reach 150 min/week of physical activity. | Behavioural | 1 |
Primary outcome
Measures of subclinical disease
Time frame: 5 years
Change in coronary calcium (EBCT)
Time frame: 5 years
Change in carotid intima media wall thickness
Time frame: 5 years
Change in vascular stiffness (PWV)
Time frame: 5 years
5 secondary outcomes
Change in waist circumference and weight
Time frame: 5 years
Change in LDL particles, triglycerides and small, medium and large LDL particles
Time frame: 5 years
Change in HDL particles
Time frame: 5 years
Change in insulin and glucose
Time frame: 5 years
Change in systolic blood pressure, diastolic blood pressure
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
- Results publication: PubMed 17087620Kuller LH, Kinzel LS, Pettee KK, Kriska AM, Simkin-Silverman LR, Conroy MB, Averbach F, Pappert WS, Johnson BD. Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Activity and Nutrition (WOMAN study) clinical trial. J Womens Health (Larchmt). 2006 Oct;15(8):962-74. doi: 10.1089/jwh.2006.15.962.
- Derived from this study: PubMed 21494228Kuller LH, Pettee Gabriel KK, Kinzel LS, Underwood DA, Conroy MB, Chang Y, Mackey RH, Edmundowicz D, Tyrrell KS, Buhari AM, Kriska AM. The Women on the Move Through Activity and Nutrition (WOMAN) study: final 48-month results. Obesity (Silver Spring). 2012 Mar;20(3):636-43. doi: 10.1038/oby.2011.80. Epub 2011 Apr 14.
- Derived from this study: PubMed 20550691Gabriel KP, McClain JJ, Schmid KK, Storti KL, High RR, Underwood DA, Kuller LH, Kriska AM. Issues in accelerometer methodology: the role of epoch length on estimates of physical activity and relationships with health outcomes in overweight, post-menopausal women. Int J Behav Nutr Phys Act. 2010 Jun 15;7:53. doi: 10.1186/1479-5868-7-53.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis H. Kuller, MD, DPH study chair
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diet, fat-restricted and Exercise in people with Cardiovascular Diseases and Atherosclerosis, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of subclinical disease (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023543, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2013.