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Follow-up on the HIGH: Low Study - the Longterm Effects of Growth Hormone
This study is not yet open for participant recruitment.
Verified by Hvidovre University Hospital, April 2008
First Received: April 16, 2008   Last Updated: April 18, 2008   History of Changes
Sponsored by: Hvidovre University Hospital
Information provided by: Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00662181
  Purpose

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.


Condition
HIV Infections
HIV-Associated Lipodystrophy Syndrome

MedlinePlus related topics: AIDS
Drug Information available for: Somatropin Somatotropin
U.S. FDA Resources
Study Type: Observational
Official Title: Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metabolism [ Time Frame: 6 months follow-up ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 46
Study Start Date: May 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
H, NH
HIV positive patients with and without lipodystrophy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants from the HIGH: low study

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00662181

Contacts
Contact: Katrine MH Andersen, stud.med. 45-36-322-108 katrine.harries.andersen@hvh.regionh.dk

Locations
Denmark
Klinisk Forskningscenter, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Ove Andersen, MD Klinisk Forskningcenter, Hvidovre Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Klinisk Forskningscenter, Hvidovre Hospital ( Forskningschef Ove Andersen )
Study ID Numbers: H-B-2008-053, 2008-41-2145
Study First Received: April 16, 2008
Last Updated: April 18, 2008
ClinicalTrials.gov Identifier: NCT00662181     History of Changes
Health Authority: Denmark: Danish Dataprotection Agency;   Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
growth hormone
quality of life
fat redistribution
sugar metabolism
fat metabolism
cytokines

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Skin Diseases
Hormone Antagonists
Acquired Immunodeficiency Syndrome
Hormones, Hormone Substitutes, and Hormone Antagonists
Quality of Life
Hormones
Immunologic Deficiency Syndromes
Virus Diseases
HIV-Associated Lipodystrophy Syndrome
HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Metabolic Disorder
Retroviridae Infections
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection
Hormones
Pathologic Processes
Syndrome
Lipodystrophy
Retroviridae Infections
RNA Virus Infections
Metabolic Diseases
Disease
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV-Associated Lipodystrophy Syndrome
HIV Infections
Skin Diseases, Metabolic
Sexually Transmitted Diseases
Lentivirus Infections
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009