Impact of Visceral Fat on the Pathogenesis of Age-related... | NCT01777984

Studies
Impact of Visceral Fat on the Pathogenesis of Age-related Macular Degeneration

NCT01777984

Sponsor

Rudolf Foundation Clinic

Status

Unknown status

Last Update Posted

Jan 29, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Age-related Macular Degeneration

Interventions

Not provided

Countries

Austria

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 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

May 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Dec 1, 2011

First Submission Date that Met QC Criteria

Jan 24, 2013

First Posted Date

Jan 29, 2013Estimated

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 24, 2013

Last Update Posted Date

Jan 29, 2013Estimated

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

The purpose of this study is to determine the relationship among the body fat distribution, especially the visceral fat, in patients with age-related macular degeneration in comparison to patients with a normal fundus.

Detailed Description

In this study the investigators want to examine the relationship among visceral fat, serum leptin levels, and high-sensitive CRP (hsCRP), Tnf-alpha, Amyloid alpha and Amyloid Beta serum levels in patients with age-related macular degeneration in comparison to patients with a normal fundus.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Measure	Description	Time Frame
visceral fat ratio		1 day

Measure	Description	Time Frame
Leptin, Amyloid, TNF alpha, CRP		1 day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

man and women over 18 years old
filled informed consent
diagnosis of age-related macular degeneration

Exclusion Criteria:

inherited retinal disease
other acquired retinal macular disease
missing informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with age-related macular degeneration, over 60

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susanne Binder	Rudolf Foundation Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rudolf Foundation Clinic		Vienna	Austria	1030	Austria

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided