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
Recruitment status was Not yet recruiting
Sponsor:
Hvidovre University Hospital
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00662181
First received: April 16, 2008
Last updated: April 18, 2008
Last verified: April 2008
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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 ] [ 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) |
| Groups/Cohorts |
|---|
|
H, NH
HIV positive patients with and without lipodystrophy
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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 ClinicalTrials.gov identifier: NCT00662181
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 | 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 |
| 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 cytokines |
Additional relevant MeSH terms:
|
HIV Infections HIV-Associated Lipodystrophy Syndrome Lipodystrophy 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 |
ClinicalTrials.gov processed this record on September 29, 2016