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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Hvidovre University Hospital.
Recruitment status was  Not yet recruiting
Information provided by:
Hvidovre University Hospital Identifier:
First received: April 16, 2008
Last updated: April 18, 2008
Last verified: April 2008
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.

HIV Infections
HIV-Associated Lipodystrophy Syndrome

Study Type: Observational
Official Title: Follow-up on the HIGH: Low Study - the Longterm Effect of Growth Hormone

Resource links provided by NLM:

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 ]

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)
HIV positive patients with and without lipodystrophy


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Forskningschef Ove Andersen, Klinisk Forskningscenter, Hvidovre Hospital Identifier: NCT00662181     History of Changes
Other Study ID Numbers: H-B-2008-053  2008-41-2145 
Study First Received: April 16, 2008
Last Updated: April 18, 2008
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

Additional relevant MeSH terms:
HIV-Associated Lipodystrophy Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Virus Diseases processed this record on May 24, 2016