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Sponsors and Collaborators: |
Pennington Biomedical Research Center Lipothera |
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Information provided by: | Pennington Biomedical Research Center |
ClinicalTrials.gov Identifier: | NCT00624416 |
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.
Condition | Intervention | Phase |
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Lipoma |
Drug: Isoproterenol;Prednisolone |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas |
Estimated Enrollment: | 10 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 |
Drug: Isoproterenol;Prednisolone
Approximately 0.2 to 0.4cc of isoproterenol-prednisolone solution (0.04 - 0.08 mg isoproterenol and 0.07 - 0.14 mg prednisolone) in one or more sites in the lipoma depending on its size, 5 days a week for 4 weeks.
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aubrey Windham, B.S. | 225-763-0920 | aubrey.windham@pbrc.edu |
Contact: Anne Chatellier, RN,CCRC | 225-763-2676 | anne.chatellier@pbrc.edu |
United States, Louisiana | |
Pennington Biomedical Research Center | Recruiting |
Baton Rouge, Louisiana, United States, 70808 | |
Contact: Frank Greenway, M.D. 225-763-2576 frank.greenway@pbrc.edu | |
Contact: Leanne Redman, Ph.D. 225-763-0947 leanne.redman@pbrc.edu | |
Principal Investigator: Leanne Redman, Ph.D. | |
Sub-Investigator: Frank Greenway, M.D. | |
Pennington Biomedical Research Center | Recruiting |
Baton Rouge, Louisiana, United States, 70808 | |
Contact: Aubrey Windham, B.S. 225-763-0920 aubrey.windham@pbrc.edu | |
Contact: Anne Chatellier, R.N. 225-763-2676 anne.chatellier@pbrc.edu | |
Principal Investigator: Leanne Redman, Ph.D. |
Principal Investigator: | Leanne Redman, Ph.D. | Pennington Biomedical Research Center |
Study Director: | Frank Greenway, M.D. | Pennington Biomedical Research Center |
Responsible Party: | Pennington Biomedical Research Center ( Leanne Redman, Ph.D. ) |
Study ID Numbers: | PBRC27015 |
Study First Received: | February 15, 2008 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00624416 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lipoma Isoproterenol Prednisolone Microdialysis |
Anti-Inflammatory Agents Neurotransmitter Agents Antineoplastic Agents, Hormonal Adrenergic Agents Adrenergic beta-Agonists Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Anti-Asthmatic Agents Methylprednisolone acetate Prednisolone acetate |
Cardiovascular Agents Neuroprotective Agents Hormones Glucocorticoids Isoproterenol Adrenergic Agonists Neoplasms, Connective and Soft Tissue Lipoma Prednisolone Peripheral Nervous System Agents Bronchodilator Agents Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Methylprednisolone Cardiotonic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Adrenergic Agonists |
Neoplasms, Connective and Soft Tissue Therapeutic Uses Methylprednisolone Hemisuccinate Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Adrenergic beta-Agonists Sympathomimetics Gastrointestinal Agents Methylprednisolone acetate Anti-Asthmatic Agents Cardiovascular Agents Glucocorticoids Protective Agents Isoproterenol Pharmacologic Actions |