NCT03644355

Asthma and Obesity Diet Versus Exercise

Completed NA Last updated 23 August 2018

What this trial tests

NA trial testing Lifestyle counseling in Obesity, Childhood in 110 participants. Completed in 4 August 2016.

Timeline

19 May 2010

Primary endpoint
4 August 2016

4 August 2016

Quick facts

Lead sponsor	Louisiana State University Health Sciences Center in New Orleans
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	19 May 2010
Primary completion	4 August 2016
Estimated completion	4 August 2016
Sites	1 location across United States

Drugs / interventions tested

• Lifestyle counseling

Conditions studied

• Obesity, Childhood — all drugs for Obesity, Childhood →
• Asthma in Children — all drugs for Asthma in Children →
• Inflammatory Response — all drugs for Inflammatory Response →
• Metabolic Syndrome — all drugs for Metabolic Syndrome →

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Who can join

Adults 13 to 19, female only, with Obesity, Childhood or Asthma in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.