NCT00624416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 22, 2012

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

February 15, 2008

Results QC Date

February 10, 2011

Last Update Submit

December 17, 2015

Conditions

Lipoma

Keywords

Obesity therapyfatdrug mechanismadipose tissuecellular pharmacology

Outcome Measures

Primary Outcomes (1)

  • The Average Percent Volume Reduction in the Lipoma.

    Baseline and 4 weeks

Secondary Outcomes (2)

  • The Number of Lipoma Increased in Volume.

    After four weeks of treatment up to one year.

  • The Number of Subjects Elected to Have the Lipoma Removed.

    After four weeks up to one year.

Study Arms (1)

Prednisolone and Isoproteronol Together

OTHER

Beta-adrenergic agonists and corticosteroid

Drug: Prednisolone synthetic cortisone and Isoproterenol together

Interventions

Prednisolone synthetic cortisone and Isoproterenol togetherDRUG

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.

Also known as: Prednisolone combined with Isoproterenol
Prednisolone and Isoproteronol Together

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

LipomaPlatelet Glycoprotein IV Deficiency

Interventions

Isoproterenol

Condition Hierarchy (Ancestors)

Neoplasms, Adipose TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Limitations and 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.

Results Point of Contact

Title
Leanne Redman
Organization
Pennington Biomedical Research Center
Leanne.Redman@pbrc.edu
225-763-0947

Study Officials

  • Leanne Redman, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

  • Frank Greenway, M.D.

    Pennington Biomedical Research Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

October 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 21, 2015

Results First Posted

June 22, 2012

Record last verified: 2015-12

Locations

US(1)