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A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

Phase 1/Phase 2
18 Years
60 Years
Not Enrolling

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Trial Information

A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Average Percent Volume Reduction in the Lipoma.

Outcome Time Frame:

Baseline and 4 weeks

Safety Issue:


Principal Investigator

Leanne Redman, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pennington Biomedical Research Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

March 2009

Related Keywords:

  • Lipoma
  • Obesity therapy
  • fat
  • drug mechanism
  • adipose tissue
  • cellular pharmacology
  • Lipoma



Pennington Biomedical Research CenterBaton Rouge, Louisiana  70808