Cardiovascular DiseasesNCT00588978
Impact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors
A study testing diet and/or exercise in people with Cardiovascular Diseases, run by Yale University at 1 site in United States.
Trial summary
The purpose of this pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- diet and/or exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2003to 1 Dec 2008
- Phase
- Interventional
- 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 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- obese postmenopausal women
- able to exercise
- non-smokers
Who cannot join
- cardiovascular disease
- medications that would interfere with outcome measures (e.g., including ACE inhibitors, lipid lowering medications, beta-blockers, etc)
- known diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Center for Clinical Investigation
New Haven, Connecticut, 06520
About this study
Official title: Longitudinal Impact of Diet and/or Exercise-induced Weight Loss on Metabolic Markers of Cardiovascular Disease
The purpose of this pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.
- Conditions
- Cardiovascular Diseases
- Being tested
- diet and/or exercise
- Keywords
- c-reactive protein, obesity, women's cardiovascular health
- Medical subject headings
- Cardiovascular Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and/or exerciseBehavioural
Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Diet alone Receives: Behavioral: diet and/or exercise |
| 2 | Active comparator | Exercise alone Receives: Behavioral: diet and/or exercise |
| 3 | Active comparator | Diet and exercise (combined) Receives: Behavioral: diet and/or exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
c-reactive protein
Measured: baseline, every 1-2 weeks during intervention , then end-of-study
Secondary outcomes (1)
HOMA (measure of insulin resistance) and sex steroids
Measured: baseline, every 1-2 weeks during intervention, then end-of-study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study start1 Aug 2003
- Primary completion1 Feb 2007
- Study completion1 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Barbara I Gulanski, MD, MPH, Principal investigator, Yale Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588978
- Sponsor's protocol ID
- 25094
- Status last verified
- Apr 2020
- First submitted
- 27 Dec 2007
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Impact of Diet and/or Exercise-induced Weight Loss on Metabolic Markers of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00588978
- Acronym / sponsor ID
- 25094
- Conditions
- Cardiovascular Diseases
- Keywords
- c-reactive protein, obesity, women's cardiovascular health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Aug 2003 (actual)
- Primary completion
- 1 Feb 2007 (actual)
- Study completion
- 1 Dec 2008 (actual)
- First posted
- 9 Jan 2008 (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 pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: diet and/or exerciseDiet alone |
| 2 | Active comparator | Behavioral: diet and/or exerciseExercise alone |
| 3 | Active comparator | Behavioral: diet and/or exerciseDiet and exercise (combined) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obese postmenopausal women
- able to exercise
- non-smokers
Key exclusion criteria (3 listed)
- cardiovascular disease
- medications that would interfere with outcome measures (e.g., including ACE inhibitors, lipid lowering medications, beta-blockers, etc)
- known diabetes
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 and/or exerciseThree arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise | Behavioural | 1, 2, 3 |
Primary outcome
c-reactive protein
Time frame: baseline, every 1-2 weeks during intervention , then end-of-study
1 secondary outcome
HOMA (measure of insulin resistance) and sex steroids
Time frame: baseline, every 1-2 weeks during intervention, then end-of-study
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 17 Apr 2020.
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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.
Barbara I Gulanski, MD, MPH principal investigator
Yale Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet and/or exercise in people with Cardiovascular Diseases, run by Yale University 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 3 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 17 Apr 2020. 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.
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?
c-reactive protein (time frame: baseline, every 1-2 weeks during intervention , then end-of-study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2020.