Metabolic Syndrome XAIRCMDNCT01548300
Environmental Triggers Of Cardiometabolic Disease
An observational study of Metabolic Syndrome X, run by Sanjay Rajagopalan at 3 sites in 2 countries.
Trial summary
The investigators posit that a multi-national collaborative effort with focused investigations in environments with the highest levels of exposure (developing countries such as China and India), are likely to provide new and much needed data on the risk posed by these variables on an individuals life-time risk for… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Metabolic Syndrome X
- How many people
- 66 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Feb 2011to Dec 2014
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from clinics affiliated with the Fuwai Hospital, PUMC. The participants will be nonsmokers with cardiometabolic disease, that are not taking anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that alter baseline insulin sensitivity, blood pressure, or endothelial function, daily use of NSAIDS is not allowed.
Who may be able to join
- Nonsmokers, 35-65 years living in a nonsmoking household.
- CM will be defined by IDF criteria (http://www.idf.org) specific for Asians [waist circumference >90 cm in males and 80 cm in females) plus any two of the following four factors: TG level: >150 mg/dL, HDL: < 40 mg/dL in males and < 50 mg/dL in females, systolic BP >130, fasting plasma glucose > 100 mg/dL or previously diagnosed type 2 diabetes.
Who cannot join
- Any active smoking within past 1 year, occupational exposures to pollutants (per discretion of investigators), self-reported daily secondhand smoke exposure > 1 hour long (workplace or home),
- History of any CV disease (e.g. previous myocardial infarction), or overt type 2 diabetes.
- Fasting glucose > 126 mg/dL or a screening BP is >160/100 mm Hg.
- Patients cannot be taking any anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that can alter baseline insulin sensitivity, BP, or endothelial function (e.g. anti-oxidants, multi-vitamins, folic acid, fish oil supplementation, L-arginine),
- Daily use of NSAIDS is not allowed; however intermittent PRN usage is acceptable.
- In the course of the year should a subject develop any of exclusion criteria they will be allowed to complete the study and the potential confounding effects will be assessed in statistical analyses.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48103
The Ohio State University
Columbus, Ohio, 43210
About this study
The investigators posit that a multi-national collaborative effort with focused investigations in environments with the highest levels of exposure (developing countries such as China and India), are likely to provide new and much needed data on the risk posed by these variables on an individuals life-time risk for type 2 diabetes and cardiovascular complications. The investigators will test this hypothesis through the establishment of a network that would lead studies on the links between exposure and adverse Chronic cardiometabolic effects and propose doing this in this as part of 3 specific aims.
Read the detailed description
In aim 1, the investigators propose to establish feasibility of such an effort in Beijing, China, an effort that will involve implementation of novel exposure assessment methodologies simultaneously with the ability to execute key surrogate outcome measures of importance in cardiovascular risk with CM diseases. In Aim 2, the association between functional cardiovascular risk variables [insulin sensitivity, Blood Pressure, endothelial function] and acute and sub-acute variations in personal black carbon and ambient particulate matter 2.5 levels among 50 individuals with the chronic cardiometabolic syndrome will be investigated. In Aim 3, the investigators will examine potential biologic pathways of importance in the proposed functional outcomes. Specifically the investigators will determine the association between ambient particulate matter 2.5 levels and alterations in adipocytokines/inflammatory variables and autonomic nervous system balance.
- Conditions
- Metabolic Syndrome X
- Keywords
- cardiometabolic disease
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled participants | Subjects will be recruited from clinics affiliated with the Fuwai Hospital, PUMC. The participants will be nonsmokers with cardiometabolic disease, that are not taking anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that alter baseline insulin sensitivity, blood pressure, or endothelial function, daily use of NSAIDS is not allowed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Death, MI (fatal and non-fatal), target vessel revascularization and hospitalization for angina at 6 months
Measured: 48 months
Secondary outcomes (1)
Inflammation markers
EPC counts and measurement of LyC6hi, CD11b+ cells
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanjay Rajagopalan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Peking Union Medical College, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Sponsor-investigator, Sanjay Rajagopalan, University of Maryland
- Investigators
- Sanjay Rajagopalan, MD, Principal investigator, Ohio State UniversityDongfeng GU, MD, Principal investigator, Peking Union Medical CollegeBrook Robert, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548300
- Sponsor's protocol ID
- HP-00059994
- Other IDs
- R01ES019616
- Acronym
- AIRCMD
- Status last verified
- Feb 2018
- First submitted
- 5 Mar 2012
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Triggers Of Cardiometabolic Disease
- ClinicalTrials.gov ID
- NCT01548300
- Acronym / sponsor ID
- AIRCMD / HP-00059994
- Conditions
- Metabolic Syndrome X
- Keywords
- cardiometabolic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Sanjay RajagopalanUniversity, hospital or other
- Collaborators
- University of Michigan, Peking Union Medical College, National Institute of Environmental Health Sciences (NIEHS)
- Study start
- Feb 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Mar 2012 (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 investigators posit that a multi-national collaborative effort with focused investigations in environments with the highest levels of exposure (developing countries such as China and India), are likely to provide new and much needed data on the risk posed by these variables on an individuals life-time risk for type 2 diabetes and cardiovascular complications. The investigators will test this hypothesis through the establishment of a network that would lead studies on the links between exposure and adverse Chronic cardiometabolic effects and propose doing this in this as part of 3 specific aims.
Detailed description
In aim 1, the investigators propose to establish feasibility of such an effort in Beijing, China, an effort that will involve implementation of novel exposure assessment methodologies simultaneously with the ability to execute key surrogate outcome measures of importance in cardiovascular risk with CM diseases. In Aim 2, the association between functional cardiovascular risk variables [insulin sensitivity, Blood Pressure, endothelial function] and acute and sub-acute variations in personal black carbon and ambient particulate matter 2.5 levels among 50 individuals with the chronic cardiometabolic syndrome will be investigated. In Aim 3, the investigators will examine potential biologic pathways of importance in the proposed functional outcomes. Specifically the investigators will determine the association between ambient particulate matter 2.5 levels and alterations in adipocytokines/inflammatory variables and autonomic nervous system balance.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled participants | – | –Subjects will be recruited from clinics affiliated with the Fuwai Hospital, PUMC. The participants will be nonsmokers with cardiometabolic disease, that are not taking anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that alter baseline insulin sensitivity, blood pressure, or endothelial function, daily use of NSAIDS is not allowed. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from clinics affiliated with the Fuwai Hospital, PUMC. The participants will be nonsmokers with cardiometabolic disease, that are not taking anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that alter baseline insulin sensitivity, blood pressure, or endothelial function, daily use of NSAIDS is not allowed.
Key inclusion criteria (2 listed)
- Nonsmokers, 35-65 years living in a nonsmoking household.
- CM will be defined by IDF criteria (http://www.idf.org) specific for Asians [waist circumference >90 cm in males and 80 cm in females) plus any two of the following four factors: TG level: >150 mg/dL, HDL: < 40 mg/dL in males and < 50 mg/dL in females, systolic BP >130, fasting plasma glucose > 100 mg/dL or previously diagnosed type 2 diabetes.
Key exclusion criteria (6 listed)
- Any active smoking within past 1 year, occupational exposures to pollutants (per discretion of investigators), self-reported daily secondhand smoke exposure > 1 hour long (workplace or home),
- History of any CV disease (e.g. previous myocardial infarction), or overt type 2 diabetes.
- Fasting glucose > 126 mg/dL or a screening BP is >160/100 mm Hg.
- Patients cannot be taking any anti-hypertensive, glucose-lowering, or lipid-lowering medications or drugs that can alter baseline insulin sensitivity, BP, or endothelial function (e.g. anti-oxidants, multi-vitamins, folic acid, fish oil supplementation, L-arginine),
- Daily use of NSAIDS is not allowed; however intermittent PRN usage is acceptable.
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
Death
Time frame: 48 months
Death, MI (fatal and non-fatal), target vessel revascularization and hospitalization for angina at 6 months
1 secondary outcome
Inflammation markers
Time frame: 30 days
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 8 Feb 2018.
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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.
Sanjay Rajagopalan, MD principal investigator
Ohio State University
Dongfeng GU, MD principal investigator
Peking Union Medical College
Brook Robert, MD principal investigator
University of Michigan
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome X, run by Sanjay Rajagopalan at 3 sites in 2 countries.
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 2 inclusion and 6 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, China. 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?
Death (time frame: 48 months). 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 8 Feb 2018.