Environmental Triggers Of Cardiometabolic Disease (AIRCMD)
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Purpose
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.
| Condition |
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Metabolic Syndrome X |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | Environmental Triggers Of Cardiometabolic Disease |
- Death [ Time Frame: 48 months ] [ Designated as safety issue: No ]Death, MI (fatal and non-fatal), target vessel revascularization and hospitalization for angina at 6 months
- Inflammation markers [ Time Frame: 30 days ] [ Designated as safety issue: No ]EPC counts and measurement of LyC6hi, CD11b+ cells
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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.
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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.
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48103 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| China, Beijing | |
| Peking Union Medical College | |
| Peking, Beijing, China, 81657 | |
| Principal Investigator: | Sanjay Rajagopalan, MD | Ohio State University |
| Principal Investigator: | Dongfeng GU, MD | Peking Union Medical College |
| Principal Investigator: | Brook Robert, MD | University of Michigan |
More Information
No publications provided
| Responsible Party: | Sanjay Rajagopalan, Professor, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT01548300 History of Changes |
| Other Study ID Numbers: | AIRCMD, R01ES019616 |
| Study First Received: | March 5, 2012 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
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cardiometabolic disease |
Additional relevant MeSH terms:
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Metabolic Syndrome X Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013