Arsenic, Disordered Glucose Homeostasis and Atherosclerosis

Atherosclerosis Clinical Trial

— EMERALD-D  

Official title:

Arsenic Exposure, Disordered Glucose Homeostasis and Atherosclerosis Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759289
• Other study ID #: 15-00725
• Status: Completed
• Start date: November 2015
• Est. completion date: September 15, 2020

Study information

• Verified date: November 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atherosclerosis
• Type 2 Diabetes (T2D)

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in platelet activity in response to arsenic exposure measured by Regression models		6 Months, 12 Months