Phase 2
N=10
Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
Lipoma
Bottom Line
View on ClinicalTrials.gov: NCT00624416 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: The Average Percent Volume Reduction in the Lipoma. — 50 Percent Volume reduction (cc^3)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prednisolone synthetic cortisone and Isoproterenol together (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Average Percent Volume Reduction in the Lipoma. |
50 | — |
| SECONDARY The Number of Lipoma Increased in Volume. |
9 | — |
| SECONDARY The Number of Subjects Elected to Have the Lipoma Removed. |
8 | — |
Summary
The purpose of this study is to test whether injected medications will increase the amount of fat released by a fat cell. We will compare prednisolone (a synthetic cortisone) combined with isoproterenol (a drug given for asthma) versus using isoproterenol alone. We will also test if injections of isoproterenol and prednisolone will shrink the size of lipomas, which are benign fatty tumors.
Eligibility Criteria
Inclusion Criteria
- You are a man or a woman between the ages of 18-60, inclusive.
- You have a body mass index (BMI) between 20 and less than 40 kg/m2. BMI is a number calculated from your height and weight.
- You have a lipoma (a benign fatty tumor) that is 1 inch or more in diameter under the skin of your abdomen or on another area of your body that is easily accessible to study (such as the thigh).
- You have not gained or lost more than 11 pounds in the last 3 months.
- Your exercise routine has been stable for the last 3 months or you are sedentary. Sedentary means you do less than 60 minutes of exercise per week.
Exclusion Criteria
- You have a history of heart or blood vessel disease.
- Your blood pressure is above 140/90 mmHg.
- You have type 1 diabetes.
- You have a history of kidney or liver disease.
- You have thyroid disease that has not been treated.
- You are a smoker.
- You use a Beta-2 (B2) adrenergic stimulator (a type of drug used to treat asthma), a beta adrenergic blocker (a type of drug used to treat blood pressure) or glucocorticoid medications (a type of drug used to treat immune system disease).
- You have a problem with alcoholism or other substance abuse.
- You are pregnant or breast feeding.
Data sourced from ClinicalTrials.gov (NCT00624416). 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.