Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents

• Status: Completed
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pennington Biomedical Research Center
• Collaborator: Leverage Innovation for Technology Transfer Fund (LSU LIFT2)
• Treatments: Albuterol; Caffeine

Criteria

Inclusion Criteria:

• Healthy males or females with a BMI ≥ 95th percentile

• Between 12 and 17 years of age inclusive

• Tanner Stage III and above

Exclusion Criteria:

• 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