LipomaPhase 1/2NCT00624416
Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
A Phase 1/2 study testing Prednisolone synthetic cortisone and Isoproterenol together in people with Lipoma, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipoma
- What is being tested?
- Prednisolone synthetic cortisone and Isoproterenol together
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Mar 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
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.
Read the 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.
- Conditions
- Lipoma
- Being tested
- Prednisolone synthetic cortisone and Isoproterenol together
- Keywords
- Obesity therapy, fat, drug mechanism, adipose tissue, cellular pharmacology
- Medical subject headings
- Lipoma, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone synthetic cortisone and Isoproterenol togetherDrug
Also called Prednisolone combined with Isoproterenol
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.
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone and Isoproteronol Together | Other | Beta-adrenergic agonists and corticosteroid Receives: Drug: Prednisolone synthetic cortisone and Isoproterenol together |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Average Percent Volume Reduction in the Lipoma.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
The Number of Lipoma Increased in Volume.
Measured: After four weeks of treatment up to one year.
The Number of Subjects Elected to Have the Lipoma Removed.
Measured: After four weeks up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LipomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lipothera
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Leanne Redman, Ph.D., Principal investigator, Pennington Biomedical Research CenterFrank Greenway, M.D., Study director, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624416
- Sponsor's protocol ID
- PBRC 27015
- Status last verified
- Dec 2015
- First submitted
- 15 Feb 2008
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Association of Beta-2 Adrenergic Agonist and Corticosteroid Injection in the Treatment of Lipomas
- ClinicalTrials.gov ID
- NCT00624416
- Acronym / sponsor ID
- PBRC 27015
- Conditions
- Lipoma
- Keywords
- Obesity therapy, fat, drug mechanism, adipose tissue, cellular pharmacology
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Lipothera
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Posted 22 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prednisolone and Isoproteronol Together | Other | Drug: Prednisolone synthetic cortisone and Isoproterenol togetherBeta-adrenergic agonists and corticosteroid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolone synthetic cortisone and Isoproterenol togetherAlso: Prednisolone combined with IsoproterenolApproximately 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. | Drug | Prednisolone and Isoproteronol Together |
Primary outcome
The Average Percent Volume Reduction in the Lipoma.
Time frame: Baseline and 4 weeks
2 secondary outcomes
The Number of Lipoma Increased in Volume.
Time frame: After four weeks of treatment up to one year.
The Number of Subjects Elected to Have the Lipoma Removed.
Time frame: After four weeks up to one year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leanne Redman, Ph.D. principal investigator
Pennington Biomedical Research Center
Frank Greenway, M.D. study director
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Prednisolone synthetic cortisone and Isoproterenol together in people with Lipoma, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Average Percent Volume Reduction in the Lipoma. (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.