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NCT03644355 · ClinicalTrials.gov registry record · NA
Asthma and Obesity Diet Versus Exercise
A NA study, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- Completed
- Registry status
- NA
- Development phase
- 110
- Enrollment target
NCT03644355 is a NA study that has completed, run by Louisiana State University Health Sciences Center in New Orleans. The registered enrollment target is 110 participants.
The verdict
NCT03644355, a NA study, has completed, sponsored by Louisiana State University Health Sciences Center in New Orleans.
- COMPLETED
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
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 inflammat
Interventions
- BEHAVIORAL Lifestyle counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2010-05-19 |
| Est. Completion | 2016-08-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03644355
The ClinicalTrials.gov registry entry for NCT03644355 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Louisiana State University Health Sciences Center in New Orleans, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lifestyle counseling is the first listed.
NCT03644355 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03644355 about?
NCT03644355 is a clinical study titled "Asthma and Obesity Diet Versus Exercise". 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 obesi...
What is the current status of trial NCT03644355?
This trial is currently completed. It is a NA study. The enrollment target is 110 participants. The study started on 2010-05-19. Estimated completion is 2016-08-04.
What interventions are being tested in trial NCT03644355?
The interventions under investigation include: Lifestyle counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT03644355?
This trial is sponsored by Louisiana State University Health Sciences Center in New Orleans, which has 45 total clinical trials registered on ClinicalTrials.gov.
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