MedPath

Factors Affecting Early Adult Lung Function

Conditions
Small Airway Disease
Metabolic Syndrome
Early Adult Lung Function
Interventions
Diagnostic Test: Forced Oscillation Technique
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.

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
Arm && Interventions
GroupInterventionDescription
New Delhi Birth CohortForced Oscillation TechniqueStudy 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.
Pune Maternal Nutrition CohortForced Oscillation TechniqueStudy 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.
Primary Outcome Measures
NameTimeMethod
Pulmonary Function Test12-18 months

To ascertain whether healthy peak lung function values have been attained

Forced oscillation technique12-18 months

To ascertain the magnitude of airway resistance and study the prevalence of small airway disease

Secondary Outcome Measures
NameTimeMethod
Serum biochemistry12-18 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

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