Asthma and Obesity Diet Versus Exercise

NCT03644355 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-08-23

No results posted yet for this study

Summary

Obesity is recognized as a pro-inflammatory condition associated with multiple chronic diseases, including asthma. The specific mechanisms linking asthma and obesity remain hypothetical. Our primary hypothesis is that inflammatory SNPs may regulate the degree of the inflammatory response, with obesity modifying the severity of the disease. In this instance, asthma that develops in the context of obesity demonstrates the potential deleterious relationship between a specific proinflammatory state (obesity) and the genetic regulators of inflammation (SNPs). Our secondary hypothesis proposes that short-term (12-weeks) weight loss by diet alone, but not exercise alone, will reduce lung specific inflammation and diminish the pro-inflammatory responses in female African American obese adolescents with asthma compared to a waiting list control group who after their initial 12 weeks then receive a combined 12-week diet plus exercise program (waiting list control/combined). A third exploratory hypothesis proposes that the frequency of identified SNPs will be significantly related to the amount of fat loss through diet, exercise or combined program and will further be mediated by specific airway and, pro-and-anti-inflammatory markers.These hypotheses will be tested using the following Specific Aims:

1. To determine the frequency of single nucleotide polymorphisms and SNP haplotypes in pro- and anti-inflammatory genes in female African American obese and non-obese asthmatic and non-asthmatic adolescents, 13-19 years or age.
2. To examine the effects of diet or exercise on lung specific inflammation (exhaled nitric oxide, \[eNO\]) and pro-and-anti-inflammatory responses in female African-American obese asthmatic and non-asthmatic adolescents compared to a waiting list control/ combined group.

In addition we will examine the following Exploratory Aim:

To determine the effects of the inflammatory SNPs in the modulation of several inflammatory markers and lung specific inflammation (eNO) in female African-American obese asthmatic and non-asthmatic adolescents before and after weight loss through diet, exercise or both.

Conditions

  • Obesity, Childhood
  • Asthma in Children
  • Inflammatory Response
  • Metabolic Syndrome
  • Nutrition Poor
  • Physical Activity
  • Behavior, Eating
  • Molecular Biology, Restriction Fragment Length Polymorphisms
  • Maternal Exposure
  • Genetic Change

Interventions

BEHAVIORAL

Lifestyle counseling

Inter-disciplinary, interactive, family based behavioral intervention for overweight children

Sponsors & Collaborators

  • Louisiana State University Health Sciences Center in New Orleans

    lead OTHER

Principal Investigators

  • Melinda S Sothern, PhD · Louisiana State University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-19
Primary Completion
2016-08-04
Completion
2016-08-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03644355 on ClinicalTrials.gov