Factors Affecting Early Adult Lung Function

NCT03187158 | Unknown DMC

• 1 other identifier: MLP5502
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Adult Lung Function; Small Airway Disease; Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Pulmonary Function Test

  To ascertain whether healthy peak lung function values have been attained

  12-18 months

• Forced oscillation technique

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

  12-18 months

Secondary Outcomes (1)

• Serum biochemistry

  12-18 months

Study Arms (2)

Pune Maternal Nutrition Cohort

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.

Diagnostic Test: Forced Oscillation Technique

New Delhi Birth Cohort

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.

Diagnostic Test: Forced Oscillation Technique

Interventions

Forced Oscillation Technique DIAGNOSTIC_TEST

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.

Also known as: Spirometry, Questionnaire, Biochemical analysis of nutritional, immunological and inflammatory biomarkers

New Delhi Birth Cohort; Pune Maternal Nutrition Cohort

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Men and Women
• years
• Mothers registered in the birth cohort
• Able to perform IOS and Spirometry

You may not qualify if:

• 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

Sponsors & Collaborators

• Council of Scientific and Industrial Research, India: lead

Study Sites (1)

Council of Scientific and Industrial Research-Institute of Genomics and Integrative Biology

New Delhi, 110007, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Metabolic Syndrome

Interventions

Spirometry; Pain Measurement

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Neurologic Examination; Physical Examination

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: July 15, 2017
• Primary Completion: July 15, 2019
• Study Completion: August 15, 2019
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)