Environmental Triggers Of Cardiometabolic Disease

Completed

Conditions studied: Metabolic Syndrome X

In brief

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.

Key facts

Study ID

NCT01548300

Run by

Sanjay Rajagopalan

People needed

66

Starts

2011-02-01

Expected to finish

2014-12-01

Last updated by the study team

2018-02-08

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• The Ohio State University — Columbus, Ohio, United States
• Peking Union Medical College — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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