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Body Composition Changes With Albuterol and Caffeine Versus Placebo in Adolescents (CAMP)

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ClinicalTrials.gov Identifier: NCT02740660
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Leverage Innovation for Technology Transfer Fund (LSU LIFT2)
Information provided by (Responsible Party):
Daniel Hsia, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Drug: Caffeine 100mg / Albuterol 4mg Drug: Placebo Behavioral: Family weight management counseling Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect on Body Composition With Albuterol and Caffeine Versus Placebo in Adolescents: A Pilot Study
Study Start Date : April 2016
Actual Primary Completion Date : October 24, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: 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.
Drug: Caffeine 100mg / Albuterol 4mg
Behavioral: Family weight management counseling
Placebo Comparator: 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.
Drug: Placebo
Behavioral: Family weight management counseling



Primary Outcome Measures :
  1. Change in Fat Mass and Lean Body Mass with Caffeine/Albuterol [ Time Frame: Baseline, Week 8 ]
    DXA Scan of obese adolescents


Secondary Outcome Measures :
  1. Change in Hunger and Satiety with Caffeine/Albuterol [ Time Frame: Baseline, Week 4, Week 8 ]
    Visual Analog Scale for Hunger and Satiety

  2. Adverse Events Reporting [ Time Frame: Week 2, Week 4, Week 6, Week 8 ]
  3. EKG [ Time Frame: Screening, Week 4, Week 8 ]
  4. Labs [ Time Frame: Screening, Week 4, Week 8 ]
    Including fasting insulin, Chemistry 26 and CBC (~7.5 mL or 1.5 teaspoons of blood)

  5. Vanderbilt Assessment scale for ADHD [ Time Frame: Baseline, Week 4, Week 8 ]
    filled out by the parent



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740660


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808-4124
Sponsors and Collaborators
Pennington Biomedical Research Center
Leverage Innovation for Technology Transfer Fund (LSU LIFT2)
Investigators
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Principal Investigator: Daniel Hsia, PhD Pennington Biomedical Research Center

Publications:
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Responsible Party: Daniel Hsia, Assistant Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02740660     History of Changes
Other Study ID Numbers: PBRC 2015-065
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Hsia, Pennington Biomedical Research Center:
Albuterol
Caffeine
Lean Body Mass
Fat Mass

Additional relevant MeSH terms:
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Albuterol
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents