Skip to main content
OpenTrials
Completed

NCT Number: NCT01548300

Environmental Triggers Of Cardiometabolic Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Death

    Time frame: 48 months

    Death, MI (fatal and non-fatal), target vessel revascularization and hospitalization for angina at 6 months

Secondary outcomes

  1. Inflammation markers

    Time frame: 30 days

    EPC counts and measurement of LyC6hi, CD11b+ cells

Sponsors and collaborators

Lead sponsor

Sanjay Rajagopalan

Other

Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)
  • Peking Union Medical College
  • University of Michigan

Registry information

Acronym: AIRCMD

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2012
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.