Clinical trial NCT02068183: World Trade Center Adolescent Health Study
Official title: Early Identification of World Trade Center Conditions in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Hypertension
Cardiovascular Risk Factor
Insulin Resistance
Stress Disorders, Post-Traumatic
Exposure to Toxic Dust
Keywords: World Trade Center exposure
cardiovascular risk
insulin resistance
post-traumatic stress
pulmonary disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 402
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for the present proposal will be drawn from the pediatric component of the WTCHR, a cohort of 71,436 adults and children who were first interviewed in 2003-04. To further investigate the associations of WTC exposures with health outcomes, we will compare health parameters in the cohort of WTCHR registrants with 225 subjects in a control cohort drawn from pediatric and adolescent clinics in Manhattan and Brooklyn.

Brief summary: The proposed study builds upon preliminary studies in self-selected populations to identify opportunities for early identification of World Trade Center-related health consequences in adolescents. If adverse health consequences are identified, proactive cardiometabolic and pulmonary screening of exposed children may be indicated, with targeted interventions intended to prevent development of chronic obstructive pulmonary disease, and adverse cardiometabolic outcomes in adulthood.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* WTCHR participants (exposed group): previous response to WTCHR, born between September 11, 1993 and September 10, 2001
* Controls who are did not live or attend school south of Canal Street on September 11, 2001, matched for age, race/ethnicity, socioeconomic status and other characteristics

Exclusion Criteria:

* Inability to follow procedures.
* Serious lung or heart condition
* Heart or lung surgery
* Uncontrolled asthma
* Current upper respiratory infection
* Pregnancy

Primary outcomes:
measure: Pulmonary Function Testing
timeFrame: One time
measure: Oscillometry
timeFrame: One time
measure: Plethysmography
timeFrame: One time
measure: Blood Pressure
timeFrame: One time
measure: Arterial Wall Stiffness
timeFrame: One time
measure: Heart Rate Variability
timeFrame: One time
measure: Insulin resistance
timeFrame: One time
Secondary outcomes:
measure: Lipid levels
timeFrame: One time
measure: Psychosocial stress and mental health outcomes
timeFrame: One time
measure: Tobacco smoke exposure
timeFrame: One time
Other outcomes:
measure: Physical activity questionnaire
timeFrame: One time
measure: Diet history questionnaire
timeFrame: One time
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU Sch of Med
name: Leonardo Trasande, MD, MPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Trasande L, Fiorino EK, Attina T, Berger K, Goldring R, Chemtob C, Levy-Carrick N, Shao Y, Liu M, Urbina E, Reibman J. Associations of World Trade Center exposures with pulmonary and cardiometabolic outcomes among children seeking care for health concerns. Sci Total Environ. 2013 Feb 1;444:320-6. doi: 10.1016/j.scitotenv.2012.11.097. Epub 2012 Dec 29.
citation: Gaylord A, Berger KI, Naidu M, Attina TM, Gilbert J, Koshy TT, Han X, Marmor M, Shao Y, Giusti R, Goldring RM, Kannan K, Trasande L. Serum perfluoroalkyl substances and lung function in adolescents exposed to the World Trade Center disaster. Environ Res. 2019 May;172:266-272. doi: 10.1016/j.envres.2019.02.024. Epub 2019 Feb 16.
citation: Trye A, Berger KI, Naidu M, Attina TM, Gilbert J, Koshy TT, Han X, Marmor M, Shao Y, Giusti R, Goldring RM, Trasande L. Respiratory Health and Lung Function in Children Exposed to the World Trade Center Disaster. J Pediatr. 2018 Oct;201:134-140.e6. doi: 10.1016/j.jpeds.2018.06.009. Epub 2018 Jul 18.
citation: Trasande L, Koshy TT, Gilbert J, Burdine LK, Marmor M, Han X, Shao Y, Chemtob C, Attina TM, Urbina EM. Cardiometabolic profiles of adolescents and young adults exposed to the World Trade Center Disaster. Environ Res. 2018 Jan;160:107-114. doi: 10.1016/j.envres.2017.09.026. Epub 2017 Sep 30.
citation: Koshy TT, Attina TM, Ghassabian A, Gilbert J, Burdine LK, Marmor M, Honda M, Chu DB, Han X, Shao Y, Kannan K, Urbina EM, Trasande L. Serum perfluoroalkyl substances and cardiometabolic consequences in adolescents exposed to the World Trade Center disaster and a matched comparison group. Environ Int. 2017 Dec;109:128-135. doi: 10.1016/j.envint.2017.08.003. Epub 2017 Sep 8.