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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00662181
Other study ID # H-B-2008-053
Secondary ID 2008-41-2145
Status Not yet recruiting
Phase N/A
First received April 16, 2008
Last updated April 18, 2008
Start date May 2008
Est. completion date January 2009

Study information

Verified date April 2008
Source Hvidovre University Hospital
Contact Katrine MH Andersen, stud.med.
Phone 45-36-322-108
Email katrine.harries.andersen@hvh.regionh.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date January 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Klinisk Forskningscenter, Hvidovre Hospital Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life 6 months follow-up No
Secondary Metabolism 6 months follow-up No
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