Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents

Completed · Not applicable · Has a placebo group

Conditions studied: Pediatric Obesity

In brief

The purpose of this study is to determine whether taking a combination of caffeine and albuterol three times per day will increase muscle and decrease fat in your child's body and to determine how these medications make your child feel. Albuterol is approved by the FDA for the treatment of asthma. It is not approved to increase muscle and decrease body fat in children.

Key facts

Study ID

NCT02740660

Run by

Pennington Biomedical Research Center

People needed

12

Starts

2016-04-01

Expected to finish

2017-10-31

Last updated by the study team

2019-10-08

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males or females with a BMI ≥ 95th percentile
• Between 12 and 17 years of age inclusive
• Tanner Stage III and above

You may not qualify if…

• Weigh less than 50 kg
• Have a family history of sudden death or hypertrophic cardiomyopathy
• Have a history of unexplained syncope
• Have a marked baseline prolongation of QT/QTc interval (QTc interval >450 ms), a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome), or use concomitant medications that prolong the QT/QTc interval
• Have history of asthma, hypertension, thyroid disease, or significant neurologic disease such as seizure disorder
• Are pregnant, planning to become pregnant, or nursing. Females who are sexually active must be using adequate contraception.
• Take a medication known to affect weight or body composition like systemic glucocorticoids, atypical anti-psychotics, or weight loss medications
• Take beta-stimulators or beta-blockers on a regular basis
• Take stimulants for attention deficit disorder
• Take monoamine oxidase inhibitors, tricyclic antidepressants, or diuretics
• Take any chronic medication that has not had a stable dose for 1 month or longer
• Have type 1 or type 2 diabetes
• Have any significant cardiac disease (such as heart failure, arrhythmias, or valve disease), uncontrolled pulmonary disease, chronic liver disease, chronic kidney disease, or chronic infectious disease
• Have any significant psychiatric illness that is unstable or untreated such as bipolar disorder, severe depression, or severe anxiety
• Have a history of suicidal ideation
• Have an allergy or hypersensitivity to albuterol
• Are unwilling to discontinue caffeine-containing products while in the study
• Are deemed unfit to participate in the study based on evaluation by the medical investigator

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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