Arsenic, Disordered Glucose Homeostasis and Atherosclerosis (EMERALD-D)

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis; Type 2 Diabetes (T2D)

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 Type: Observational
• Enrollment (Actual): 279

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Disordered Glucose Homeostasis

• Group A: Prediabetes, A1c 5.7-6.4%
• Group B: T2D A1c 6.5-7.9% without T2D medications T2D A1c ≥ 8% with/without T2D medications
• Control patients (Group C): Normal glucose homeostasis

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group A; Prediabetes glycohemoglobin test A1c 5.7-6.4%
Group B; T2D glycohemoglobin test= A1c 6.5-7.9% without T2D medications T2D glycohemoglobin test=A1c ≥ 8.0% with/without T2D medications
Group C; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Jonathan Newman, MPH, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Arsenic
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: 15-00725

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No