Pediatric Obesity
Conditions
Keywords
Albuterol, Caffeine, Lean Body Mass, Fat Mass
Brief 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.
Detailed description
Previous studies done at Pennington Biomedical have demonstrated that the equivalent of oral albuterol 4mg three times a day (tid) with oral caffeine 100mg tid reduces body fat and increases lean tissue in rodents more than the addition of the effect of the two components separately. The combination of albuterol with caffeine changed body composition without changing food intake. An adult male taking albuterol 4 mg orally tid plus caffeine 100mg orally tid increased lean mass by 1.25% and decreased fat mass by 1.2% over a two month period. These effects are expected to be even greater in a growing adolescent. This pilot project will take the first step towards trying to understanding the safety and potential efficacy of this drug combination. The prospect of using inexpensive medications already approved in the pediatric population for the treatment of asthma as a novel treatment for adolescent obesity addresses a medical need that is presently unmet. Food restriction in adolescence is not only difficult to accomplish, but it also raises concerns about growth and development. A medication approved for the treatment of obesity in the adolescent age group that improves body composition by reducing body fat and increasing lean tissue without needing to restrict food intake would be a useful tool for physicians who address the treatment of obesity in adolescents. Albuterol is a medication, approved for ages 6 and older, used for the treatment of asthma and has also been shown to increase muscle strength and lean body mass in children with spinal muscular atrophy and in healthy young men during an exercise training program. A drug approved for the treatment of adolescent obesity that increases lean tissue, decreases fat tissue and can be given in conjunction with lifestyle modifications would be welcomed by both pediatricians who treat these adolescents and by adolescents who are stigmatized by their obesity. A provisional patent has been submitted by Pennington Biomedical Research Center to protect the combination of caffeine and albuterol in a 1:25 ratio for synergistically increasing muscle mass and decreasing fat mass as a potential treatment for obesity in adolescents. This study will be a double-blinded, randomized, placebo-controlled, pilot study in which subjects will be randomized to receive either placebo or a combination of Albuterol 4 mg and Caffeine 100mg three times per day orally for a total of 8 weeks. Each subject will continue on the study intervention for the entire duration of treatment
Interventions
DRUGCaffeine 100mg / Albuterol 4mg
DRUGPlacebo
BEHAVIORALFamily weight management counseling
Sponsors
Leverage Innovation for Technology Transfer Fund (LSU LIFT2)
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat Mass With Caffeine/Albuterol | Baseline, Week 8 | DXA Scan of obese adolescents |
| Change in Lean Mass With Caffeine/Albuterol | Baseline, Week 8 | DXA Scan of obese adolescents |
| Change in Weight With Caffeine/Albuterol | Baseline, Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | Week 2, Week 4, Week 6, Week 8 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caffeine 100mg / Albuterol 4mg One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.
Caffeine 100mg / Albuterol 4mg
Family weight management counseling | 6 |
| Placebo One capsule 3 times per day orally for a total of 8 weeks and family weight management counseling for a total of 8 weeks.
Placebo
Family weight management counseling | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Caffeine 100mg / Albuterol 4mg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 14 years STANDARD_DEVIATION 1.5 | 14 years STANDARD_DEVIATION 1.7 | 15 years STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 1 Participants |
| Region of Enrollment United States | 6 participants | 12 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 5 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change in Fat Mass With Caffeine/Albuterol
DXA Scan of obese adolescents
Time frame: Baseline, Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine 100mg / Albuterol 4mg | Change in Fat Mass With Caffeine/Albuterol | 0.97 kg | Standard Deviation 1.11 |
| Placebo | Change in Fat Mass With Caffeine/Albuterol | -0.21 kg | Standard Deviation 1.41 |
Primary
Change in Lean Mass With Caffeine/Albuterol
DXA Scan of obese adolescents
Time frame: Baseline, Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine 100mg / Albuterol 4mg | Change in Lean Mass With Caffeine/Albuterol | 1.34 kg | Standard Deviation 1.22 |
| Placebo | Change in Lean Mass With Caffeine/Albuterol | 0.88 kg | Standard Deviation 1.16 |
Primary
Change in Weight With Caffeine/Albuterol
Time frame: Baseline, Week 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caffeine 100mg / Albuterol 4mg | Change in Weight With Caffeine/Albuterol | 2.57 kg | Standard Deviation 1.92 |
| Placebo | Change in Weight With Caffeine/Albuterol | 1.05 kg | Standard Deviation 2.19 |
Secondary
Number of Participants With Adverse Events
Time frame: Week 2, Week 4, Week 6, Week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Caffeine 100mg / Albuterol 4mg | Number of Participants With Adverse Events | 5 Participants |
| Placebo | Number of Participants With Adverse Events | 2 Participants |