N/A
N=12
Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents
Pediatric Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02740660 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change in Fat Mass With Caffeine/Albuterol — 0.97; -0.21 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Caffeine 100mg / Albuterol 4mg (Drug); Placebo (Drug); Family weight management counseling (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fat Mass With Caffeine/Albuterol |
0.97; -0.21 | — |
| PRIMARY Change in Lean Mass With Caffeine/Albuterol |
1.34; 0.88 | — |
| PRIMARY Change in Weight With Caffeine/Albuterol |
2.57; 1.05 | — |
| SECONDARY Number of Participants With Adverse Events |
5; 2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02740660). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.