Metabolic SyndromeMeta-HealthNCT00336869
Partnership Programs to Reduce Cardiovascular Disparities- Morehouse- Emory Partnership
An observational study of Metabolic Syndrome, run by Emory University at 2 sites in United States.
Trial summary
The theme of this Morehouse-Emory Partnership Program focuses on elucidating the etiologic basis of ethnic differences in obesity-related CVD and discovering new intervention strategies to ameliorate CV health in all communities. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- How many people
- 680 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2005to Jan 2010
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: African American and White residents age 30-65
Who may be able to join
- Our methodological approach will involve a random digit-dialing cross-sectional survey of 4000 Metro Atlanta area AA and white residents (ages 30-65 years). This aim will focus on using well-validated survey instruments to examine self-reported perceptions of psychosocial stress, neighborhood segregation factors and health beliefs related to weight/weight control. These parameters will be assessed in relation to the differential prevalence of three major outcomes: (1) self-reported maladaptive cardiovascular behaviors that predispose to obesity-related CVD (ie high fat/sodium and low fruit/vegetables dietary intake and physical inactivity); (2) obesity; and (3) hypertension.
- This study will address the following research questions: Are the observed racial differences in maladaptive health behaviors (diet/inactivity) and MetS components (obesity, hypertension) associated with: a) perceived psychosocial stress, and if so, does depression, neighborhood factors or health beliefs around weight and weight control modify this relationship?
- -
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Morehouse CRC
Atlanta, Georgia, 30310
Emory GCRC
Atlanta, Georgia, 30329
About this study
The theme of this Morehouse-Emory Partnership Program focuses on elucidating the etiologic basis of ethnic differences in obesity-related CVD and discovering new intervention strategies to ameliorate CV health in all communities. The proposed Program uses a multi-disciplinary strategy to systematically characterize ethnic differences in obesity-related CVD by drawing upon the fields of physiology, psychology, biochemistry, vascular biology, public health, nursing and clinical medicine.
Read the detailed description
Emerging evidence indicates that there are ethnicity-specific differences in the profile of biochemical, metabolic and physiological perturbations associated with obesity. The implications of these ethnic differences remain to be further defined. Several epidemiologic studies have shown that vascular disease and its cardiovascular complications, carry significantly higher morbidity and mortality in African Americans compared with Caucasians.1-3 These observations may be partly explained by a higher prevalence of cardiovascular disease risk factors, such as essential hypertension, diabetes mellitus, and tobacco use among African Americans.4-6 However, the pathophysiological processes underlying this racial predisposition have not been fully elucidated.7 It is likely that the etiologic basis of ethnic disparities in cardiovascular disease is multi-factorial and involves dynamic gene-environment interactions in which variances in behavior and the social context are critical determinants.
The proposed Program recognizes the importance of incorporating both biological factors and social determinants in the analysis of cardiovascular disparities
- Conditions
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startDec 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Emory 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Morehouse School of Medicine
- Responsible party
- Principal investigator, Arshed A. Quyyumi, Emory University
- Investigators
- Arshed Quyyumi, MD, Principal investigator, Emory UniversityGary Gibbons, MD, Principal investigator, Morehouse School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336869
- Sponsor's protocol ID
- IRB00024856
- Other IDs
- 1024-2004
- Acronym
- Meta-Health
- Status last verified
- Nov 2013
- First submitted
- 12 Jun 2006
- Last updated
- 18 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership Programs to Reduce Cardiovascular Disparities- Morehouse- Emory Partnership
- ClinicalTrials.gov ID
- NCT00336869
- Acronym / sponsor ID
- Meta-Health / IRB00024856
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Morehouse School of Medicine
- Study start
- Dec 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Jun 2006 (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 theme of this Morehouse-Emory Partnership Program focuses on elucidating the etiologic basis of ethnic differences in obesity-related CVD and discovering new intervention strategies to ameliorate CV health in all communities. The proposed Program uses a multi-disciplinary strategy to systematically characterize ethnic differences in obesity-related CVD by drawing upon the fields of physiology, psychology, biochemistry, vascular biology, public health, nursing and clinical medicine.
Detailed description
Emerging evidence indicates that there are ethnicity-specific differences in the profile of biochemical, metabolic and physiological perturbations associated with obesity. The implications of these ethnic differences remain to be further defined. Several epidemiologic studies have shown that vascular disease and its cardiovascular complications, carry significantly higher morbidity and mortality in African Americans compared with Caucasians.1-3 These observations may be partly explained by a higher prevalence of cardiovascular disease risk factors, such as essential hypertension, diabetes mellitus, and tobacco use among African Americans.4-6 However, the pathophysiological processes underlying this racial predisposition have not been fully elucidated.7 It is likely that the etiologic basis of ethnic disparities in cardiovascular disease is multi-factorial and involves dynamic gene-environment interactions in which variances in behavior and the social context are critical determinants.
The proposed Program recognizes the importance of incorporating both biological factors and social determinants in the analysis of cardiovascular disparities
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African American and White residents age 30-65
Key inclusion criteria (3 listed)
- Our methodological approach will involve a random digit-dialing cross-sectional survey of 4000 Metro Atlanta area AA and white residents (ages 30-65 years). This aim will focus on using well-validated survey instruments to examine self-reported perceptions of psychosocial stress, neighborhood segregation factors and health beliefs related to weight/weight control. These parameters will be assessed in relation to the differential prevalence of three major outcomes: (1) self-reported maladaptive cardiovascular behaviors that predispose to obesity-related CVD (ie high fat/sodium and low fruit/vegetables dietary intake and physical inactivity); (2) obesity; and (3) hypertension.
- This study will address the following research questions: Are the observed racial differences in maladaptive health behaviors (diet/inactivity) and MetS components (obesity, hypertension) associated with: a) perceived psychosocial stress, and if so, does depression, neighborhood factors or health beliefs around weight and weight control modify this relationship?
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 18 Nov 2013.
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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.
Arshed Quyyumi, MD principal investigator
Emory University
Gary Gibbons, MD principal investigator
Morehouse School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Emory University at 2 sites 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 1 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 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 18 Nov 2013.