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Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone

Primary Purpose

HIV Infections, HIV-Associated Lipodystrophy Syndrome

Status
Unknown status
Phase
Locations
Denmark
Study Type
Observational
Intervention
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for HIV Infections focused on measuring growth hormone, quality of life, fat redistribution, sugar metabolism, fat metabolism, cytokines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years of age
  • Participated in and completed the HIGH: low study
  • informed consent signed

Exclusion Criteria:

  • Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study

Sites / Locations

  • Klinisk Forskningscenter, Hvidovre Hospital

Arms of the Study

Arm 1

Arm Type

Arm Label

H, NH

Arm Description

HIV positive patients with and without lipodystrophy

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

Metabolism

Full Information

First Posted
April 16, 2008
Last Updated
April 18, 2008
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00662181
Brief Title
Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone
Official Title
Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone
Study Type
Observational

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2008 (Anticipated)
Study Completion Date
January 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A follow-up study on the randomized, controlled, double-blind HIGH: low study. We will examine the participants from the HIGH: low study min. 6 months after finishing the HIGH: low study. We will look at the parameters: quality of life, sugar-metabolism, fat-metabolism, fat-redistribution and cytokines. The study will use the participants control visit, and the only additional examination will be the danish MOS-HIV questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV-Associated Lipodystrophy Syndrome
Keywords
growth hormone, quality of life, fat redistribution, sugar metabolism, fat metabolism, cytokines

7. Study Design

Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
H, NH
Arm Description
HIV positive patients with and without lipodystrophy
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
Metabolism
Time Frame
6 months follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years of age Participated in and completed the HIGH: low study informed consent signed Exclusion Criteria: Patient stopped at Hvidovre Hospital, or didn't finish the HIGH: low study
Study Population Description
Participants from the HIGH: low study
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrine MH Andersen, stud.med.
Phone
45-36-322-108
Email
katrine.harries.andersen@hvh.regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ove Andersen, MD
Organizational Affiliation
Klinisk Forskningcenter, Hvidovre Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinisk Forskningscenter, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrine Andersen, Stud.med.
Phone
45-36-322-108
Email
katrine.harries.andersen@hvh.regionh.dk
First Name & Middle Initial & Last Name & Degree
Ove Andersen, MD

12. IPD Sharing Statement

Links:
URL
http://www.hvidovrehospital.dk
Description
The official website for Hvidovre Hospital

Learn more about this trial

Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone

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