Factors Affecting Early Adult Lung Function

• Conditions: Small Airway Disease; Metabolic Syndrome; Early Adult Lung Function

• Registration Number: NCT03187158
• Lead Sponsor: Council of Scientific and Industrial Research, India

Brief Summary

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.

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 Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-15
• Study Start: 2017-07-15
• Primary Completion: 2019-07-15
• Study Completion: 2019-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum biochemistry	12-18 months	To study nutritional, immunological and inflammatory biomarkers correlated with both lung function and metabolic syndrome

Trial Locations

Locations (1)

Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology; 🇮🇳 New Delhi, India