Environmental Triggers Of Cardiometabolic Disease

NCT ID: NCT01548300

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2014-12-31

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.

Conditions

Metabolic Syndrome X

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: collaborator

Sanjay Rajagopalan

OTHER

Sponsor Role: lead

Responsible Party

Sanjay Rajagopalan

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sanjay Rajagopalan, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Dongfeng GU, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Brook Robert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

The Ohio State University

Columbus, Ohio, United States

Peking Union Medical College

Beijing, Beijing Municipality, China

Countries

United States; China

Other Identifiers

R01ES019616

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00059994

Identifier Type: -

Identifier Source: org_study_id