Environmental Triggers Of Cardiometabolic Disease
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 35 - 65 |
| Updated: | 2/10/2018 |
| Start Date: | February 2011 |
| End Date: | December 2014 |
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.
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.
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.
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.
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.
We found this trial at
3
sites
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
Click here to add this to my saved trials
Click here to add this to my saved trials