Environmental Triggers Of Cardiometabolic Disease (AIRCMD)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Michigan
Peking Union Medical College
Information provided by (Responsible Party):
Sanjay Rajagopalan, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01548300
First received: March 5, 2012
Last updated: March 7, 2012
Last verified: March 2012
  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
Metabolic Syndrome X

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Environmental Triggers Of Cardiometabolic Disease

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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.

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
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01548300

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
Sponsors and Collaborators
Sanjay Rajagopalan
University of Michigan
Peking Union Medical College
Investigators
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:
cardiometabolic disease

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 30, 2014