Arsenic, Disordered Glucose Homeostasis and Atherosclerosis

Completed

• Conditions: Atherosclerosis; Type 2 Diabetes (T2D)

• Registration Number: NCT02759289
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

• No known cardiovascular, cerebrovascular or peripheral arterial disease
• Able and willing to provide written informed consent for the study

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multiple linear regression to estimate the difference in brachial artery reactivity associated with a 1-Standard Deviation change in urinary arsenic	6 Months, 12 Months
Change in platelet activity in response to arsenic exposure measured by Regression models	6 Months, 12 Months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States