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Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy

Primary Purpose

Lipodystrophy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Lipodystrophy focused on measuring endocrine disorders, rare disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical diagnosis of regional lipoatrophy Control subjects: Women aged 18 to 65 Weight 90% to 150% of ideal No significant acute or chronic illness --Patient Characteristics-- Negative pregnancy test required of fertile women

Sites / Locations

  • University of Texas Medical Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 1999
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT00004329
Brief Title
Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy
Study Type
Observational

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Texas

4. Oversight

5. Study Description

Brief Summary
OBJECTIVES: I. Determine the response in plasma norepinephrine concentration and plasma glycerol to the agonist (clonidine) and the antagonist (yohimbine) of the alpha-2 adrenergic receptor in 6 patients with regional lipoatrophy and in 6 controls. II. Determine the full sequence of the alpha-2 adrenergic receptor structural gene in genomic DNA from peripheral blood leukocytes.
Detailed Description
PROTOCOL OUTLINE: Antihypertensives are held, beginning 3 days before the first study day. An oral challenge is administered as follows: clonidine on day 1, yohimbine on day 2. The order of administration is reversed in alternate subjects. Timed measurements of norepinephrine, glycerol, and free fatty acids follow each challenge. Structural gene sequencing is evaluated for each participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy
Keywords
endocrine disorders, rare disease

7. Study Design

Enrollment
12 (false)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical diagnosis of regional lipoatrophy Control subjects: Women aged 18 to 65 Weight 90% to 150% of ideal No significant acute or chronic illness --Patient Characteristics-- Negative pregnancy test required of fertile women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fannie Smith
Organizational Affiliation
University of Texas
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0209
Country
United States

12. IPD Sharing Statement

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Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy

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