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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 15, 2008 | ||||||||
| Last Updated Date | April 16, 2009 | ||||||||
| Start Date ICMJE | October 2007 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Lipoma volume at the end of the treatment period compared to baseline. [ Time Frame: Weekly ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Lipoma measurement [ Time Frame: Weekly ] [ Designated as safety issue: Yes ] | ||||||||
| Change History | Complete list of historical versions of study NCT00624416 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas | ||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | Lipomas are 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, pulse and lipoma will be measured and subjects will be asked how they feel. At the end of the treatment period the physical examination, blood test and electrocardiogram will be repeated. The insertion of the microdialysis probes under the skin into the fat tissue could be uncomfortable, but numbing medication will be injected first to prevent this problem. At higher doses, isoproterenol could lower blood pressure and increase pulse rate. This should not happen at the doses used, but blood pressure and pulse will be monitored throughout the study. Prednisolone, at higher doses, could decrease the body's production of cortisone. This should not happen at the doses being used, but cortisone in the body will be measured during the trial. Blood tests involve the discomfort of a needle going through the skin of the arm, possible bruising and rarely fainting or infection. Trained technicians and sterile needles will minimize these risks. |
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| Study Phase | Phase I, Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Lipoma | ||||||||
| Intervention ICMJE | Drug: Isoproterenol;Prednisolone | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | December 2008 | ||||||||
| Estimated Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00624416 | ||||||||
| Responsible Party | Leanne Redman, Ph.D., Pennington Biomedical Research Center | ||||||||
| Study ID Numbers ICMJE | PBRC27015 | ||||||||
| Study Sponsor ICMJE | Pennington Biomedical Research Center | ||||||||
| Collaborators ICMJE | Lipothera | ||||||||
| Investigators ICMJE |
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| Information Provided By | Pennington Biomedical Research Center | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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