Clinical trial NCT03187158: Factors Affecting Early Adult Lung Function
Official title: Factors Affecting Early Adult Lung Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Adult Lung Function
Small Airway Disease
Metabolic Syndrome
Lead sponsor: Council of Scientific and Industrial Research, India
Sponsor class: OTHER_GOV
First posted: 2017-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary Function Test
timeFrame: 12-18 months
measure: Forced oscillation technique
timeFrame: 12-18 months
Secondary outcomes:
measure: Serum biochemistry
timeFrame: 12-18 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology
Study officials:
References: