Asthma and Obesity Diet Versus Exercise

Completed · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03644355

Run by

Louisiana State University Health Sciences Center in New Orleans

People needed

110

Starts

2010-05-19

Expected to finish

2016-08-04

Last updated by the study team

2018-08-23

Who can join

Age: 13 and older, up to 19. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• African American Females with an age of 13-19 years will be recruited. Our aim is to target high school age youth who are most likely to exhibit autonomy and authority to control both their nutrition and exercise regimens. In addition this age range is representative of the age group most likely to access school based health centers for recruitment purposes. Lastly, the study includes the collection of blood samples for the purpose of examining varied physiologic parameters that are affected by maturation. Participants above the age of 13 are most likely pubertal and thus, less likely to be affected by maturation issues.

You may not qualify if…

• Presence of other chronic pulmonary or systemic disease.
• Presence of moderate or severe atopic dermatitis or allergic rhinitis.
• Severe asthmatic based upon American Thoracic Society (ATS) standards and/or NIH guidelines.
• Acute lower respiratory infection in the last 2 weeks before baseline eNO evaluation.
• Pregnant are nursing mothers Study participants and parents (s) will be advised of the known risks and consequences associated with the testing and also of the reasonably known risks and consequences of not undergoing testing.
• Severe or uncontrolled asthmatics will not be allowed to participate.
• Participants with a recent (in the last 2 weeks) lower respiratory infection will not be allowed to participate.

Where it is running

• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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