Follow-up on the HIGH: Low Study - the Longterm Effects o... | NCT00662181

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

NCT00662181

Sponsor

Hvidovre University Hospital

Status

Unknown status

Last Update Posted

Apr 21, 2008Estimated

Enrollment

46Estimated

Phase

Not provided

Conditions

HIV Infections
HIV-Associated Lipodystrophy Syndrome

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-41-2145

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Oct 2008Estimated

Completion Date

Jan 2009Estimated

First Submitted Date

Apr 16, 2008

First Submission Date that Met QC Criteria

Apr 18, 2008

First Posted Date

Apr 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2008

Last Update Posted Date

Apr 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Label	Type	Description	Intervention Names
H, NH		HIV positive patients with and without lipodystrophy

Measure	Description	Time Frame
Quality of life		6 months follow-up

Measure	Description	Time Frame
Metabolism		6 months follow-up

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Participants from the HIGH: low study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katrine MH Andersen, stud.med.	Contact	45-36-322-108		katrine.harries.andersen@hvh.regionh.dk

Overall Officials

Name	Affiliation	Role
Ove Andersen, MD	Klinisk Forskningcenter, Hvidovre Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinisk Forskningscenter, Hvidovre Hospital		Hvidovre	Hvidovre	2650	Denmark

Label	URL
The official website for Hvidovre Hospital	View source

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D039682	HIV-Associated Lipodystrophy Syndrome

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

Not provided

Browse Branches

Not provided