Obesity Clinical Trial
Official title:
A Randomized, Placebo-Controlled Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics. (The GLITZ Asthma Study)
Asthmatics who are significantly overweight tend to have more severe symptoms, more flare
ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.
Researchers believe this occurs because excess adipose tissue (fat) in the bosy can cause
higher-than-normal levels of leptin and lower levels of adiponectin in the blood.
The researchers of this study are testing a medication called pioglitazone in overweight
asthmatics because they believe it can help regulate leptin and adiponectin and that this
may improve symptoms of asthma.
Participants in this study will be randomly assigned (like the flip of a coin) to
pioglitazone or placebo (an inactive pill). They will be given study medication to take
every day for 12 weeks (3 months).
Participants will complete a number of asthma-related questionnaires and a variety of
pulmonary function tests. Participants will undergo physical exams, an electrocardiogram,
and blood sampling to measure leptin, adiponectin, markers of inflammation, blood cell
counts, glucose levels, BNP hormone levels, and liver function.
To monitor participants throughout the study, follow-up visits will be done at 2, 6, and 12
weeks after starting study drug. At these visits many of the pulmonary function tests and
questionnaires will be repeated.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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