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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662181
Recruitment Status : Unknown
Verified April 2008 by Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2008
Last Update Posted : April 21, 2008
Information provided by:
Hvidovre University Hospital

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.

Condition or disease
HIV Infections HIV-Associated Lipodystrophy Syndrome

Study Type : Observational
Estimated Enrollment : 46 participants
Official Title: Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone
Study Start Date : May 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Hormones
U.S. FDA Resources

HIV positive patients with and without lipodystrophy

Primary Outcome Measures :
  1. Quality of life [ Time Frame: 6 months follow-up ]

Secondary Outcome Measures :
  1. Metabolism [ Time Frame: 6 months follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants from the HIGH: low study

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662181

Contact: Katrine MH Andersen, 45-36-322-108

Klinisk Forskningscenter, Hvidovre Hospital Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Katrine Andersen,    45-36-322-108   
Principal Investigator: Ove Andersen, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Principal Investigator: Ove Andersen, MD Klinisk Forskningcenter, Hvidovre Hospital

Additional Information:
Responsible Party: Forskningschef Ove Andersen, Klinisk Forskningscenter, Hvidovre Hospital Identifier: NCT00662181     History of Changes
Other Study ID Numbers: H-B-2008-053
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: April 21, 2008
Last Verified: April 2008

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

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