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| Tracking Information | |||||
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| First Received Date ICMJE | October 18, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | November 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00004329 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Alpha-2 Adrenergic Receptor Dysfunction in Regional Lipoatrophy | ||||
| Official Title ICMJE | |||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening | ||||
| Condition ICMJE | Lipodystrophy | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 12 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Female | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00004329 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 199/11884, UTMB-437 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | University of Texas | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Research Resources (NCRR) | ||||
| Verification Date | December 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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