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

April 18, 2008 updated by: Hvidovre University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Hvidovre, Denmark, 2650
        • Klinisk Forskningscenter, Hvidovre Hospital
        • Contact:
        • Principal Investigator:
          • Ove Andersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Participants from the HIGH: low study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
H, NH
HIV positive patients with and without lipodystrophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 6 months follow-up
6 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Metabolism
Time Frame: 6 months follow-up
6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Investigators

  • Principal Investigator: Ove Andersen, MD, Klinisk Forskningcenter, Hvidovre Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 21, 2008

Last Update Submitted That Met QC Criteria

April 18, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-B-2008-053
  • 2008-41-2145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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