Clinical Trial: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
Brief 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.
Detailed Summary:
Lipomas are benign, non-cancerous fatty tumors that occur under the skin and make a bump that can be easily felt and often seen. The current treatment for lipomas is surgery. Isoproterenol, a medication used for the treatment of asthma and approved for injection under the skin, is known to cause fat cells to give up their fat. The fat cells become resistant to isoproterenol with repeated use. Prednisolone, a synthetic cortisone medication used to treat immune problems like allergy and approved for injection under the skin, keeps the fat cells from becoming resistant to isoproterenol. It is not known, if the fat cells in lipomas act like other fat cells or if the combination of isoproterenol and prednisolone injections would shrink lipomas without surgery. This study is designed to test this possibility.
Subjects will have a screening visit, 2 microdialysis visits a week apart, 20 treatment visits 5 days per week for 4 weeks, and up to 12 follow-up visits a year after treatment visits. During screening, subjects will have a history, physical exam, blood testing, electrocardiogram and a pregnancy testing if female with reproductive capacity. The first microdialysis visit will consist of placing two microdialysis catheters under the skin after the area is numbed. One microdialysis catheter will be in the lipoma and the other under the skin 2 inches away. The microdialysis catheter will connect to a pump, isoproterenol will be infused and the amount of fat breakdown measured. One week later prednisolone will be injected into the lipoma and under the skin 2 inches away. The microdialysis visit will be repeated 24 hours later.
Treatment will consist of injecting the lipoma 5 days a week with a mixture of isoproterenol and prednisolone in the Pennington clinic as a diabetic would inject insulin. Each week the blood pressure, puls
Sponsor: Pennington Biomedical Research Center
Current Primary Outcome: The Average Percent Volume Reduction in the Lipoma. [ Time Frame: Baseline and 4 weeks ]
Original Primary Outcome: Lipoma measurement [ Time Frame: Weekly ]
Current Secondary Outcome:
- The Number of Lipoma Increased in Volume. [ Time Frame: After four weeks of treatment up to one year. ]
- The Number of Subjects Elected to Have the Lipoma Removed. [ Time Frame: After four weeks up to one year. ]
Original Secondary Outcome:
Information By: Pennington Biomedical Research Center
Dates:
Date Received: February 15, 2008
Date Started: October 2007
Date Completion:
Last Updated: December 17, 2015
Last Verified: December 2015
