Environmental Triggers Of Cardiometabolic Disease

NCT01548300 | Completed

• 2 other identifiers: HP-00059994R01ES019616
• Study Type: observational
• Target: 66
• Locations: 2 countries
• Sites: 3

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.

Conditions

Metabolic Syndrome X

Keywords

cardiometabolic disease

Outcome Measures

Primary Outcomes (1)

• Death

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

  48 months

Secondary Outcomes (1)

• Inflammation markers

  30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanjay Rajagopalan: lead
• University of Michigan: collaborator
• Peking Union Medical College: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (3)

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Peking Union Medical College

Beijing, Beijing Municipality, 81657, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sanjay Rajagopalan, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Dongfeng GU, MD

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

• Brook Robert, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 8, 2012
• Study Start: February 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

CN (1); US (2)