Serum Citrate in Diagnosis and Follow-up for Glaucoma | NCT00804063

Studies
Serum Citrate in Diagnosis and Follow-up for Glaucoma

NCT00804063

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jan 8, 2015Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Glaucoma

Interventions

drawing blood sample

Countries

Switzerland

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

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Dec 5, 2008

First Submission Date that Met QC Criteria

Dec 5, 2008

First Posted Date

Dec 8, 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

Jan 7, 2015

Last Update Posted Date

Jan 8, 2015Estimated

Name	Class
Kantonsspital Baselland Bruderholz	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Glaucoma might be a mitochondria associated disease. Since citrate is a major component in mitochondrial metabolism its determination in blood might serve as a biomarker.

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

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		glaucoma patients	Procedure: drawing blood sample
2		non-glaucoma controls	Procedure: drawing blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
drawing blood sample	Procedure	fasting blood sample	1 2

Measure	Description	Time Frame
serum citrate level		1

Measure	Description	Time Frame
urine citrate		1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age> 18 years
glaucoma

Exclusion Criteria:

Active ocular inflammation
Ocular Hypertension
Nephropathy
Alcohol-, Drug abuse
Mitochondriopathy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

tertiary university center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Goldblum, MD	University Hospital, Basel, Switzerland	Principal Investigator
Josef Flammer, MD	University Hospital, Basel, Switzerland	Study Chair
Selim Orguel, MD	University Hospital, Basel, Switzerland	Study Director
Stephan Fraenkl, MD	University Hospital, Basel, Switzerland	Principal Investigator
Fabrizio Branca, MD	University Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel	Canton of Basel-City	4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided