The Effect of a Diabetic- and a Kidney-like Environment o... | NCT01423279

Studies
The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Cultured EC and SMC

NCT01423279

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Sep 1, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Endothelial Dysfunction
Disorder of Smooth Muscle

Interventions

Not provided

Countries

Israel

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
0074-11-MMC	Other Identifier	Meir Medical Center , Israel

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Aug 2022Estimated

Completion Date

Aug 2022Estimated

First Submitted Date

Aug 24, 2011

First Submission Date that Met QC Criteria

Aug 24, 2011

First Posted Date

Aug 25, 2011Estimated

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

Aug 31, 2021

Last Update Posted Date

Sep 1, 2021Actual

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

This research is NOT part of an interventional trial, however the investigators use umbilical cord after birth for isolating endothelial and smooth muscle cells for academic research.

Detailed Description

Isolation and culturing of endothelial and smooth muscle muscles for academic research

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

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of a Diabetic- and a Kidney-like environment on gene and protein expression in mono- and co-cultured endothelial and smooth muscle cells		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal pregnancy

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Women after normal birth

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sydney Benchetrit, MD	Nephrology dept. Meir Medical Center, Kfar Saba , Israel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory of Renal Physiology, Meir Medical Center ,	Recruiting	Kfar Saba			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20089511	Background	Zitman-Gal T, Green J, Pasmanik-Chor M, Oron-Karni V, Bernheim J. Endothelial pro-atherosclerotic response to extracellular diabetic-like environment: possible role of thioredoxin-interacting protein. Nephrol Dial Transplant. 2010 Jul;25(7):2141-9. doi: 10.1093/ndt/gfp768. Epub 2010 Jan 19.
21236342	Background