Arsenic, Disordered Glucose Homeostasis and Atherosclerosis
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/18/2018 |
| Start Date: | November 2015 |
| End Date: | December 2020 |
| Contact: | Stanley Cobos |
| Email: | Stanley.Cobos@nyumc.org |
Arsenic Exposure, Disordered Glucose Homeostasis and Atherosclerosis Protocol
Investigators will recruit 250 subjects; Group A will consist of 100 prediabetic patients
with an A1c of 5.7%-6.4%. Group B will consist of 100 patients with uncontrolled T2D defined
as either a) an A1c of 6.5%-7.9% without diabetes medications or b) an A1c ≥ 8.0% with or
without diabetes medications. Group C will include 50 participants without T2D or known
cardiovascular disease to serve as control comparisons.
with an A1c of 5.7%-6.4%. Group B will consist of 100 patients with uncontrolled T2D defined
as either a) an A1c of 6.5%-7.9% without diabetes medications or b) an A1c ≥ 8.0% with or
without diabetes medications. Group C will include 50 participants without T2D or known
cardiovascular disease to serve as control comparisons.
Patients with prediabetes have an elevated risk of cardiovascular disease (CVD).
Cardiovascular disease (CVD) is also the leading cause of morbidity and mortality in patients
with Type 2 Diabetes. There remains an unmet clinical need to identify modifiable risk
factors for CVD in patients with disordered glucose homeostasis, including prediabetes and
T2D. Exposure to inorganic arsenic and other environmental toxicants may be novel targets for
CVD risk reduction for these patients. However, there have been no clinical studies of
environmental exposures on vascular function and thrombotic risk among patients with
prediabetes and growing understanding of environmental exposures as modifiable risk factors
for CVD, and can have an impact by: (1) describing the role of environmental exposures for
patients with or at risk for T2D; (2) identifying T2D patients at higher risk for the adverse
biological effects of environmental exposures; and (3) informing health policies and
treatment pathways to reduce the risk of these exposures.
Investigators will evaluate the association between inorganic arsenic exposure and measures
of vascular function, estimate the association between inorganic arsenic exposure and
measures of thrombotic risk and will explore the independent association between
environmental exposures other than inorganic arsenic and measures of vascular function and
thrombotic risk.
Cardiovascular disease (CVD) is also the leading cause of morbidity and mortality in patients
with Type 2 Diabetes. There remains an unmet clinical need to identify modifiable risk
factors for CVD in patients with disordered glucose homeostasis, including prediabetes and
T2D. Exposure to inorganic arsenic and other environmental toxicants may be novel targets for
CVD risk reduction for these patients. However, there have been no clinical studies of
environmental exposures on vascular function and thrombotic risk among patients with
prediabetes and growing understanding of environmental exposures as modifiable risk factors
for CVD, and can have an impact by: (1) describing the role of environmental exposures for
patients with or at risk for T2D; (2) identifying T2D patients at higher risk for the adverse
biological effects of environmental exposures; and (3) informing health policies and
treatment pathways to reduce the risk of these exposures.
Investigators will evaluate the association between inorganic arsenic exposure and measures
of vascular function, estimate the association between inorganic arsenic exposure and
measures of thrombotic risk and will explore the independent association between
environmental exposures other than inorganic arsenic and measures of vascular function and
thrombotic risk.
Inclusion Criteria:
- No known cardiovascular, cerebrovascular or peripheral arterial disease
- Able and willing to provide written informed consent for the study
Exclusion Criteria:
- Unable to speak Spanish or English
- Active smoking (within the past year)
- Autoimmune, rheumatologic or inflammatory disease
- Known active cancer receiving treatment
- Pregnancy
- Anemia (hemoglobin < 9 mg/dl)
- Chronic kidney disease (CrCl < 30ml/min)
- Known Coronary Artery Disease (CAD; prior stents or CABG)
- Congestive Heart Failure
- Known Peripheral Arterial Disease (PAD; lower extremity revascularization surgery OR
lower extremity stenting)
- Known prior stroke or transient ischemic attack (TIA) (mini-stroke or
temporary/transient stroke)
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Jonathan Newman, MD
Phone: 646-501-2897
New York University School of Medicine NYU School of Medicine has a proud history that...
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