Factors Affecting Early Adult Lung Function (FEAL)

Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant of the rate of lung function decline during the later years of life. The attainment of a healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment and nutrition) and exposure to environmental toxicants and nutrition during childhood and early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on maternal nutrition and anthropometry can provide invaluable insight into the factors affecting lung function growth and their effect sizes in the Indian population. Therefore, in this observational study, the Investigator will be collecting data on lung function, current nutritional and environmental exposures and linking it to pre and peri natal data of the same participants in order to understand lung function growth and the reasons for an early decline in the Indian population, using a life course approach.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome; Small Airway Disease; Early Adult Lung Function
• Intervention / Treatment: Diagnostic test: Forced Oscillation Technique

Detailed Description

Introduction:

Attainment of peak healthy lung function during the 18-26 yr window is a strong determinant of the rate of lung function decline during the later years of life. The attainment of a healthy peak lung function is mediated by pre and peri natal exposures ( in utero environment and nutrition) and exposure to environmental toxicants and nutrition during childhood and early adulthood. Towards this Indian birth cohorts, having collected comprehensive data on maternal nutrition and anthropometry can provide invaluable insight into the factors affecting lung function growth and their effect sizes in the Indian population. Therefore, in this observational study, the Investigator will be collecting data on lung function, current nutritional and environmental exposures and linking it to pre and peri natal data of the same participants in order to understand lung function growth and the reasons for an early decline in the Indian population, using a life course approach.

Sampling:

F1 generation of previously registered Indian Birth Cohorts, having collected comprehensive data on maternal exposures, nutrition and anthropometry.

Techniques Employed:

Spirometry , Forced OscillationTechnique, Anthropometry, Questionnaire, Biochemical analysis of nutritional, immunomodulatory and inflammatory biomarkers.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110007
    • Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Both birth cohorts,will be instrumental in understanding the link between intergenerational nutrition, early life exposures metabolism and lung health, particularly in rapidly developing lungs. Subjects have already been enrolled in the cohort. Complete datasets of offspring, now aged around 18-30 years, are available through this study, starting from pre-natal environment.

Description

Inclusion Criteria:

• Men and Women
• 18-30 years
• Mothers registered in the birth cohort
• Able to perform IOS and Spirometry

Exclusion Criteria:

• Major systemic diseases like cardiac or renal problems
• Clinically significant anemia
• Bone deformity of chest or spine
• muscular weakness
• Otherwise unable to participate in spirometry

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pune Maternal Nutrition Cohort; Study has been planned on the F1 generation of the mothers recruited under the PMNS study at Diabetes Unit, KEM-Pune. Data on maternal nutrition, exposures and anthropometry have been collected, in the F1 generation. This study will be adding cross sectional lung function measurement, biochemical analyses for nutritional, immunological and inflammatory biomarkers.	Diagnostic test: Forced Oscillation Technique; F.O.T. method can be used to assess obstruction in the large and small peripheral airways , Changes in lung volumes will be measured using a digital spirometer . Every participant will be asked to sit straight, seal the mouthpiece completely with their lips, breathe in fully, blow as hard as possible into the mouthpiece, emptying the lungs completely., Whole blood collected on site (20 mL from every participant, for about 23 metabolites) will be separated into cells and serum. A detailed questionnaire assessing respiratory health, demographic data, habits, and environmental exposure has been developed and validated by Chest Research Foundation.; Other Names: Questionnaire; Spirometry; Biochemical analysis of nutritional, immunological and inflammatory biomarkers
New Delhi Birth Cohort; Study has been planned on the F1 generation of the mothers recruited under the New Delhi Birth Cohort in New Delhi, India. Data on maternal nutrition, exposures and anthropometry have been collected, in the F1 generation, the study will be adding cross sectional lung function measurement, biochemical analyses for nutritional, immunological and inflammatory biomarkers.	Diagnostic test: Forced Oscillation Technique; F.O.T. method can be used to assess obstruction in the large and small peripheral airways , Changes in lung volumes will be measured using a digital spirometer . Every participant will be asked to sit straight, seal the mouthpiece completely with their lips, breathe in fully, blow as hard as possible into the mouthpiece, emptying the lungs completely., Whole blood collected on site (20 mL from every participant, for about 23 metabolites) will be separated into cells and serum. A detailed questionnaire assessing respiratory health, demographic data, habits, and environmental exposure has been developed and validated by Chest Research Foundation.; Other Names: Questionnaire; Spirometry; Biochemical analysis of nutritional, immunological and inflammatory biomarkers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Function Test	To ascertain whether healthy peak lung function values have been attained	12-18 months
Forced oscillation technique	To ascertain the magnitude of airway resistance and study the prevalence of small airway disease	12-18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum biochemistry	To study nutritional, immunological and inflammatory biomarkers correlated with both lung function and metabolic syndrome	12-18 months

Collaborators and Investigators

• Sponsor: Council of Scientific and Industrial Research, India

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2017
• Primary Completion (Anticipated): July 15, 2019
• Study Completion (Anticipated): August 15, 2019

Study Registration Dates

• First Submitted: June 12, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 15, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: MLP5502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data sets and/or documents to be shared : Lung function data, biomarker data, retrospective maternal anthropometry data will be shared as a complete dataset, but with a participant ID which will be delinked from actual participant identity. The ID will only be linked to the participant in the event that an abnormality is detected and the participant may require intervention. Data will be shared via a common excel sheet available to all investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No