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Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00624416
Recruitment Status : Completed
First Posted : February 27, 2008
Results First Posted : June 22, 2012
Last Update Posted : December 21, 2015
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Lipoma Drug: Prednisolone synthetic cortisone and Isoproterenol together Phase 1 Phase 2

Detailed Description:

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, 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
Study Start Date : October 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Prednisolone and Isoproteronol Together
Beta-adrenergic agonists and corticosteroid
Drug: Prednisolone synthetic cortisone and Isoproterenol together
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.
Other Name: Prednisolone combined with Isoproterenol

Primary Outcome Measures :
  1. The Average Percent Volume Reduction in the Lipoma. [ Time Frame: Baseline and 4 weeks ]

Secondary Outcome Measures :
  1. The Number of Lipoma Increased in Volume. [ Time Frame: After four weeks of treatment up to one year. ]
  2. The Number of Subjects Elected to Have the Lipoma Removed. [ Time Frame: After four weeks up to one year. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00624416

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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
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Principal Investigator: Leanne Redman, Ph.D. Pennington Biomedical Research Center
Study Director: Frank Greenway, M.D. Pennington Biomedical Research Center
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Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center Identifier: NCT00624416    
Other Study ID Numbers: PBRC 27015
First Posted: February 27, 2008    Key Record Dates
Results First Posted: June 22, 2012
Last Update Posted: December 21, 2015
Last Verified: December 2015
Keywords provided by Frank Greenway, Pennington Biomedical Research Center:
Obesity therapy
drug mechanism
adipose tissue
cellular pharmacology
Additional relevant MeSH terms:
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Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents