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OpenTrials
Completed

NCT Number: NCT02759289

Arsenic, Disordered Glucose Homeostasis and Atherosclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Multiple linear regression to estimate the difference in brachial artery reactivity associated with a 1-Standard Deviation change in urinary arsenic

    Time frame: 6 Months, 12 Months

  2. Change in platelet activity in response to arsenic exposure measured by Regression models

    Time frame: 6 Months, 12 Months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Arsenic Exposure, Disordered Glucose Homeostasis and Atherosclerosis Protocol

Acronym: EMERALD-D

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 3, 2016
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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