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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662181
First Posted: April 21, 2008
Last Update Posted: April 21, 2008
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.
Information provided by:
Hvidovre University Hospital
  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

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 ]

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00662181


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

Locations
Denmark
Klinisk Forskningscenter, Hvidovre Hospital Not yet recruiting
Hvidovre, Denmark, 2650
Contact: Katrine Andersen, Stud.med.    45-36-322-108    katrine.harries.andersen@hvh.regionh.dk   
Principal Investigator: Ove Andersen, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Ove Andersen, MD Klinisk Forskningcenter, Hvidovre Hospital
  More Information

Additional Information:
Responsible Party: Forskningschef Ove Andersen, Klinisk Forskningscenter, Hvidovre Hospital
ClinicalTrials.gov Identifier: NCT00662181     History of Changes
Other Study ID Numbers: H-B-2008-053
2008-41-2145
First Submitted: April 16, 2008
First Posted: April 21, 2008
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
cytokines

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
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
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs