Clinical trial NCT01548300: Environmental Triggers Of Cardiometabolic Disease
Official title: Environmental Triggers Of Cardiometabolic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome X
Keywords: cardiometabolic disease
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Peking Union Medical College
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2012-03-08
Enrollment: 66
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

Brief 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 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.

Eligibility 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.

Primary outcomes:
measure: Death
timeFrame: 48 months
Secondary outcomes:
measure: Inflammation markers
timeFrame: 30 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Peking
country: China
facility: Peking Union Medical College
state: Beijing
Study officials:
affiliation: Ohio State University
name: Sanjay Rajagopalan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College
name: Dongfeng GU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Brook Robert, MD
role: PRINCIPAL_INVESTIGATOR
References: