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Factors Affecting Early Adult Lung Function (FEAL)

C

Council of Scientific & Industrial Research (CSIR)

Status

Unknown

Conditions

Small Airway Disease
Early Adult Lung Function
Metabolic Syndrome

Treatments

Diagnostic Test: Forced Oscillation Technique

Study type

Observational

Funder types

Other

Identifiers

NCT03187158
MLP5502

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Pune Maternal Nutrition Cohort
Description:
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.
Treatment:
Diagnostic Test: Forced Oscillation Technique
New Delhi Birth Cohort
Description:
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.
Treatment:
Diagnostic Test: Forced Oscillation Technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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