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Metabolomics of World Trade Center-Lung Injury: Biomarker Validation, Longitudinal Assessment, and Dietary Intervention

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ClinicalTrials.gov Identifier: NCT03581006
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a randomized-controlled unblinded clinical trial to investigate dietary intervention on metabolic biomarker assessment in World Trade Center (WTC) Lung Injury (LI) in firefighters. The purpose of this study is to evaluate biomarkers of metabolic dysregulation that have previously been found to predict WTC-LI in a case cohort study selected from the entire exposed firefighter cohort, and attempt to alter these metabolites using dietary intervention and a technology-supported behavioral modification program. Investigators will measure Pre/Post global metabolic expression in WTC-exposed, symptomatic firefighter serum sampled after 6-month intervention, as well as clinical outcomes of WTC-LI in the study group vs controls.

Condition or disease Intervention/treatment
Lung Injury Particulate Matter Inhalation Injury Dietary Supplement: Low-Calorie Mediterranean Diet Combination Product: Technology based monitoring and behavioral participation Other: Usual care group

Detailed Description:
Investigators propose to measure metabolites on this expanded cohort with serum sampled before and after 6-month intervention with calorie restricted Mediterranean diet to: 1) determine the effects of a technology assisted calorie restricted diet on metabolic risk and lung function; 2) determine differences between usual care and intervention group using genomics and metabolomics that may be targetable markers for further evaluation; 3) quantify the metabolome and evaluate pre/post changes in BMI, FEV1, FeNo, vascular stiffness, and overall quality of life; and 4) explore dietary modification as treatment of WTC-LI. The biomarker profile of the cohort control will be useful for discovering biomarker associations with other disease manifestations such as: bronchial wall thickening on CT, obstruction on FEV1 /FVC ratio, bronchodilator response, methacholine reactivity, and other definitions of loss of FEV 1 . This cohort control will be an asset to future studies.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Metabolomics of World Trade Center-Lung Injury: Biomarker Validation, Longitudinal Assessment, and Dietary Intervention
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Group/Cohort Intervention/treatment
Intervention Group

This observational cohort study will follow firefighters enrolled in Monitoring and Treatment Program. Investigators will include firefighters in the validation cohort who were present at the WTC site within 3 days of 9/11, have consent, and have abnormal post-9/11 lung function.

This intervention group will undergo technology based monitoring and behavioral participation in a dietary and exercise program with the intent of weight loss and compliance with a low-calorie Mediterranean diet.

Dietary Supplement: Low-Calorie Mediterranean Diet
Participants in the intervention group will receive 6 months of education and behavioral counseling with self-monitoring to help them adopt a Mediterranean-style, calorie-restricted diet, and engage in physical activity
Other Name: LoCalMed

Combination Product: Technology based monitoring and behavioral participation
Intervention participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary
Other Name: LoCalMed

Control (Usual care) Group

This observational cohort study will follow firefighters enrolled in Monitoring and Treatment Program. Investigators will include firefighters in the validation cohort who were present at the WTC site within 3 days of 9/11, have consent, and have abnormal post-9/11 lung function.

This group will receive no dietary or behavioral intervention. They will continue usual care with their home physicians.

Other: Usual care group
Control group, who will receive no dietary or behavioral intervention during the trial
Other Name: Control group




Primary Outcome Measures :
  1. Pulmonary Function using FEV Measure [ Time Frame: 4 Years ]
    Forced expiratory volume (FEV) at timed intervals of 0.5, 1.0 (FEV1), 2.0, and 3.0 seconds using spirometer that measures the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled.

  2. Body mass index (BMI) [ Time Frame: 4 Years ]
    Body mass (weight in kg) divided by square of the body height (measured in meters), expressed in units kg/m^2


Secondary Outcome Measures :
  1. St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: 4 Years ]
    Airways-disease specific paper questionnaire assessing symptoms, effect on activity level, and impact on quality of life.

  2. Electrocardiogram (EKG) [ Time Frame: 4 years ]
    Non-invasive brief electrical recording of heart rate and rhythm using electrodes placed on the chest

  3. Fraction of exhaled nitrous oxide (FENO) [ Time Frame: 4 years ]
    Simple breathing test to measure airway inflammation as often seen in asthma or particulate matter lung injury, measured in ppb.

  4. Pulse Wave Velocity (PWV) [ Time Frame: 4 years ]
    Non-invasive measurement to ascertain vascular stiffness, by measuring the velocity at which the blood pressure pulse propogates through the circulatory system. This is done using a simple non-invasive blood pressure cuff assessment at the carotid and femoral arteries. It is measured as a velocity, in meters/per second.

  5. 6-minute walk test (6MWT) [ Time Frame: 4 years ]
    Simple exercise capacity assessment measuring distance walked over 6 minutes, measured in meters.

  6. Individual metabolomic profile - blood sample [ Time Frame: 4 years ]
    Routine blood testing via sterile phlebotomy to assess metabolic biomarkers that may or may not predict lung injury. These metabolites are generated in all individuals based on their dietary and exercise habits, underlying comorbidities, and unique metabolism. Measured in routine blood samples, and quantified based on unique chemical composition of that molecule. There is no additional risk to the human subject aside that of venipuncture.

  7. Individual genomic profile - saliva sample [ Time Frame: 4 years ]
    Simple home collection of sputum/saliva sample using a buccal swab kit, provided to the human subject. Saliva will be used to generate a genetic profile unique to that individual, reported as chromosomes, genes, and proteins that may predict lung injury. There is no risk to the human subject aside that of providing a sputum sample. All individual information is de-identified for personal protection.

  8. Individual microbiome profile - stool sample [ Time Frame: 4 years ]
    Simple home collection of a stool sample using a sterile collection kit, provided to the human subject. Stool will be used to generate a microbiome profile unique to that individual, reported as bacterial species found in the gut flora, that may predict lung injury. There is no risk to the human subject aside that of providing a stool sample. All individual information is de-identified for personal protection.

  9. Short-form-36 (SF-36) questionnaire [ Time Frame: 4 years ]
    Generalized paper questionnaire for self-assessment of mental health, general health perception, and overall quality of life

  10. Routine vital signs - Heart Rate [ Time Frame: 4 years ]
    Brief assessment of heart rate (pulse) measured in beats/per minute

  11. Routine vital signs - Blood Pressure [ Time Frame: 4 years ]
    Subjects who have spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY.

  12. Routine vital signs - Body temperature [ Time Frame: 4 years ]
    Brief assessment of body temperature using a basic thermometer under the tongue, measured in degrees Fahrenheit

  13. Neck circumference [ Time Frame: 4 years ]
    Assessment of neck circumference using basic measuring tape, recorded in centimeters

  14. Waist circumference [ Time Frame: 4 years ]
    Assessment of waist circumference using basic measuring tape, recorded in centimeters

  15. Bioelectrical impedance analysis (BIA) [ Time Frame: 4 years ]
    Assessment of lean body mass and total body fat percentage using an InBody bioelectrical impedance analysis scale.

  16. Food Frequency Questionnaire [ Time Frame: 4 years ]
    Paper assessment of typical dietary intake over previous one month, multiple choice answers


Biospecimen Retention:   Samples With DNA
-FEV1<LLN to define WTC-LI; resistant subjects had the highest FEV1(FEV1≥107% predicted and within one-standard deviation(SD) of the highest FEV1% predicted of the study cohort).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male only
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
FDNY rescue and recovery worker with 9/11 exposure with documented WTC-LI by spirometry criteria.
Criteria

Inclusion Criteria:

  1. Age 21-90.
  2. Born male sex and currently identify as genetic male
  3. FDNY rescue and recovery worker.
  4. Documented WTC exposure.
  5. Enrolled in the FDNY WTC Health Program
  6. Subjects are willing and able to consent for themselves to study enrollment
  7. Subjects are willing and able to participate in study procedures
  8. Are able to perform their activities of daily living independently
  9. Are either light duty or retired FDNY Firefighters
  10. Have an FEV1 less than the LLN of predicted for age/sex/weight documented at any time after 9/11/2001.
  11. Have a BMI>27 kg/m2 and <50kg/m2
  12. Willing and able to modify their diet and activity level.
  13. Subjects who have a spirometry available within the last 36 months, and at their post-9/11 visits at the FDNY
  14. Demonstrate minimal proficiency using a smart phone
  15. Have means to accommodate transportation to/from in-person visits

Exclusion Criteria:

  1. Have pre-existing and documented conditions or concurrent diagnoses, including (and not necessarily limited to) active cancer, severe heart disease, significant cognitive impairment, eating disorders, significant psychiatric illness, end-stage COPD, severe pulmonary hypertension, or organ transplant.
  2. Concomitant use of interfering medication(s) or devices currently or within the month prior to enrollment, including anti-retrovirals, human monoclonal antibodies, supplemental daytime oxygen, and insulin pumps.
  3. Severe gastrointestinal issues or illnesses that would prevent adherence to the proposed diets.
  4. Severe kidney disease requiring dialysis
  5. Severe liver disease requiring frequent medical intervention
  6. Participating in other diet modification studies.
  7. High dose steroid (>20mg prednisone or equivalent) or other hormonal treatments/chemotherapy use in the last month, including testosterone supplementation.
  8. Life-expectancy < 6 months
  9. BMI ≥50 kg/m2 or ≤27 kg/m2
  10. Recent significant intentional or unintentional weight loss, defined as over 5% reduction in total body weight over the last month. (Blackburn Criteria).
  11. Significant or severe alcohol abuse disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581006


Contacts
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Contact: Jessica Riggs, MD 646-501-6783 jessica.riggs@nyumc.org
Contact: Rachel Lam 646-501-6783 rachel.lam@nyumc.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Jessica Riggs, MD    646-501-6783    jessica.riggs@nyumc.org   
Principal Investigator: Anna Nolan         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Anna Nolan, MD NYU Langone Health
Additional Information:

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03581006    
Other Study ID Numbers: 17-00127
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
World Trade Center
Firefighters
FDNY
9/11
Metabolomics
FIREHOUSE
Additional relevant MeSH terms:
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Lung Injury
Wounds and Injuries
Respiratory Tract Diseases
Lung Diseases
Thoracic Injuries