World Trade Center Adolescent Health Study
|ClinicalTrials.gov Identifier: NCT02068183|
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : January 24, 2017
|Condition or disease|
|Asthma Hypertension Cardiovascular Risk Factor Insulin Resistance Stress Disorders, Post-Traumatic Exposure to Toxic Dust|
The study will assess the potential for longer-latency cardiometabolic and pulmonary effects of early life exposure to the World Trade Center (WTC) disaster, and to identify opportunities for early identification of WTC-related health consequences. Preliminary data from the only investigators who regularly provide clinical care to children who lived/attended school near the WTC site identified decrements in spirometry associated with dust cloud exposure, and a remarkably high frequency of cardiometabolic risk factors. Findings from this clinically, self-selected population cannot be extrapolated to the entire population of children who were exposed to the disaster but nonetheless suggest that further study is warranted of the possible metabolic and cardiovascular consequences of WTC exposures. If associated with WTC exposures in a larger, more representative sample, two new and innovative techniques, oscillometry and pulse wave velocity assessment, hold great promise for earlier detection of WTC-related pulmonary and cardiometabolic disease, for whom dietary, environmental and medication interventions may prevent disease progression in later life.
The study will recruit 225 adolescents who respond to the WTC Health Registry (WTCHR), the most representative pediatric population and best-characterized from an environmental exposure standpoint. Connecting the study to the WTCHR also presents efficiency of federal resource utilization, providing more objective clinical data to support self-reported findings of increased persistent respiratory symptoms captured by the WTCHR, thereby improving reliability of the registry data. We will compare pulmonary and cardiometabolic outcomes to carefully matched (age, race/ethnicity, gender, and socioeconomic status) and unexposed control (not resident/attending school south of Houston Street on September 11, 2001) populations from NYU School of Medicine affiliated primary care (private and public clinics).
|Study Type :||Observational|
|Actual Enrollment :||402 participants|
|Official Title:||Early Identification of World Trade Center Conditions in Adolescents|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
World Trade Center exposed group
After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the World Trade Center exposed group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.
Unexposed comparison group
After informed consent, anthropometric and blood pressure/brachial artery distensibility assessments; physical examination and environmental and respiratory history questionnaire completion; heart rate variability measurement; and spirometry/IOS will be performed on the unexposed comparison group. A research assistant well trained in pediatric phlebotomy will collect 23 mL of fasting blood. Spirometry and IOS, diet diary collection, lung volumes by plethysmography, and arterial wall stiffness.
- Pulmonary Function Testing [ Time Frame: One time ]We will perform spirometry according to standards outlined by the American Thoracic Society and the European Respiratory Society. Specifically, we will assess forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), FEV1/FVC ratio, and forced expiratory flow over 25-75% of the vital capacity (FEF25-75%; Jaeger Masterscreen IOS; Carefusion, Yorba Linda, CA). National Health and Nutrition Examination Survey (NHANES) III reference equations will be used to determine normative values, with statistical analysis to be applied to percents of predicted volumes based on these norms.
- Oscillometry [ Time Frame: One time ]Oscillometry provides a noninvasive measure of the impedance to airflow within the lung. An externally-generated pressure impulse is applied during tidal breathing in a seated position for 30 seconds, and volume and flow measurements are made.
- Plethysmography [ Time Frame: One time ]Measured lung volumes will include total lung capacity (TLC), vital capacity (VC), residual volume (RV), and functional residual capacity (FRC) and will be compared to normative values, using established pediatric reference equations.
- Blood Pressure [ Time Frame: One time ]We will perform assess systolic (first Korotkoff phase) and diastolic (fifth Korotkoff phase) BP three consecutive times in all participants.
- Arterial Wall Stiffness [ Time Frame: One time ]Pulse Wave Velocity (PWV) will be measured using the SphygmoCor CPV System (AtCor Medical, Sydney, Australia). PWV measures the speed for the pressure wave generated by cardiac ejection to reach the periphery.
- Heart Rate Variability [ Time Frame: One time ]Assessment of Heart Rate Variability (HRV) will be performed using the SphgymoCor SCOR-CPV device (AtCor Medical, Sydney, Australia).
- Insulin resistance [ Time Frame: One time ]Fasting insulin and blood glucose will be assessed.
- Lipid levels [ Time Frame: One time ]Fasting blood draw will be performed.
- Psychosocial stress and mental health outcomes [ Time Frame: One time ]
- WTC disaster trauma—We will measure psychologically relevant WTC exposure, using questions about direct exposure, family/friend exposure, and media exposure.
- Other lifetime trauma
- Substance abuse, and other diagnoses
- Post-traumatic stress disorder
- Functional impairment
- Mental health service utilization
- Tobacco smoke exposure [ Time Frame: One time ]We will measure tobacco smoke exposure from salivary cotinine.
- Physical activity questionnaire [ Time Frame: One time ]Questionnaire adapted from the International Physical Activity Questionnaire-Short last seven days
- Diet history questionnaire [ Time Frame: One time ]web-based Diet History Questionnaire II developed by the National Cancer Institute
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068183
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Leonardo Trasande, MD, MPP||NYU Sch of Med|