Environmental Triggers Of Cardiometabolic Disease

Metabolic Syndrome X Clinical Trial

— AIRCMD  

Official title:

Environmental Triggers Of Cardiometabolic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548300
• Other study ID #: HP-00059994
• Secondary ID: R01ES019616
• Status: Completed
• Phase: N/A
• First received: March 5, 2012
• Last updated: February 7, 2018
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2018
• Source: University of Maryland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome X

Locations

Country	Name	City	State
China	Peking Union Medical College	Peking	Beijing
United States	University of Michigan	Ann Arbor	Michigan
United States	The Ohio State University	Columbus	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Sanjay Rajagopalan	National Institute of Environmental Health Sciences (NIEHS), Peking Union Medical College, University of Michigan

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	Death, MI (fatal and non-fatal), target vessel revascularization and hospitalization for angina at 6 months	48 months
Secondary	Inflammation markers	EPC counts and measurement of LyC6hi, CD11b+ cells	30 days