Arsenic, Disordered Glucose Homeostasis and Atherosclerosis
EMERALD-D
Arsenic Exposure, Disordered Glucose Homeostasis and Atherosclerosis Protocol
1 other identifier
observational
279
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2020
CompletedNovember 13, 2020
November 1, 2020
4.9 years
April 27, 2016
November 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
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
Eligibility Criteria
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
You may qualify if:
- No known cardiovascular, cerebrovascular or peripheral arterial disease
- Able and willing to provide written informed consent for the study
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Newman, MPH
New York University Medical School
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 3, 2016
Study Start
November 1, 2015
Primary Completion
September 15, 2020
Study Completion
September 15, 2020
Last Updated
November 13, 2020
Record last verified: 2020-11