Factors Affecting Early Adult Lung Function

Metabolic Syndrome Clinical Trial

— FEAL  

Official title:

Factors Affecting Early Adult Lung Function

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03187158
• Other study ID #: MLP5502
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 12, 2017
• Last updated: June 14, 2017
• Start date: July 15, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: June 2017
• Source: Council of Scientific and Industrial Research, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: August 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Adult Lung Function
• Metabolic Syndrome
• Metabolic Syndrome X
• Pulmonary Disease, Chronic Obstructive
• Small Airway Disease

Intervention

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.

Locations

Country	Name	City	State
India	Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Council of Scientific and Industrial Research, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary Function Test	To ascertain whether healthy peak lung function values have been attained	12-18 months
Primary	Forced oscillation technique	To ascertain the magnitude of airway resistance and study the prevalence of small airway disease	12-18 months
Secondary	Serum biochemistry	To study nutritional, immunological and inflammatory biomarkers correlated with both lung function and metabolic syndrome	12-18 months