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

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00624416
• Collaborator: Lipothera (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 17
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Oct 1, 2007
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Prednisolone combined with Isoproterenol

Outcome Measures

Primary Outcome Measures

1. The Average Percent Volume Reduction in the Lipoma. [Baseline and 4 weeks]

Secondary Outcome Measures

1. The Number of Lipoma Increased in Volume. [After four weeks of treatment up to one year.]

2. The Number of Subjects Elected to Have the Lipoma Removed. [After four weeks up to one year.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

• Pennington Biomedical Research Center
• Lipothera

Investigators

• Principal Investigator: Leanne Redman, Ph.D., Pennington Biomedical Research Center
• Study Director: Frank Greenway, M.D., Pennington Biomedical Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00624416
• Other Study ID Numbers: PBRC 27015
• First Posted: Feb 27, 2008
• Last Update Posted: Dec 21, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Frank Greenway, Principal Investigator, Pennington Biomedical Research Center: Obesity therapy; fat; drug mechanism; adipose tissue; cellular pharmacology
• Additional relevant MeSH terms: Lipoma; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Cortisone; Isoproterenol; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	Prednisolone and Isoproteronol
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Prednisolone and Isoproteronol
Arm/Group Description	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.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	7 70%
Male	3 30%
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	The Average Percent Volume Reduction in the Lipoma.
Time Frame	Baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisolone and Isoproteronol
Arm/Group Description	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.
Measure Participants	10
Measure Lipoma	10
Mean (Full Range) [Percent Volume reduction (cc^3)]	50 (0.002)

2. Secondary Outcome

Title	The Number of Lipoma Increased in Volume.
Time Frame	After four weeks of treatment up to one year.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisolone and Isoproteronol
Arm/Group Description	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.
Measure Participants	10
Measure Lipoma	10
Number [Lipomas]	9

3. Secondary Outcome

Title	The Number of Subjects Elected to Have the Lipoma Removed.
Time Frame	After four weeks up to one year.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prednisolone and Isoproteronol
Arm/Group Description	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.
Measure Participants	10
Measure Lipoma	10
Number [participants]	8 80%

Adverse Events

Arm/Group Title	Prednisolone and Isoproteronol
Arm/Group Description	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.
All Cause Mortality
	Prednisolone and Isoproteronol
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Prednisolone and Isoproteronol
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Prednisolone and Isoproteronol
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

The single case that did not have an increase in lipoma volume showed variability which may have been because of a small lipoma making accurate measurement difficult.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.