## Protocol Section
### Identification Module
**NCT ID:** NCT01423279

**Brief Title:** The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Cultured EC and SMC

**Official Title:** 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

#### Organization Study ID Info
**ID:** MMC11-0074CTIL
#### Organization
**Class:** OTHER
**Full Name:** Meir Medical Center
#### Secondary ID Infos
**Domain:** Meir Medical Center , Israel
**ID:** 0074-11-MMC
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2022-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-09-01

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-31

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-02

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2011-08-25
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-24
**Study First Submit QC Date:** 2011-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Meir Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### 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

### Conditions Module

**Conditions:**

- Endothelial Dysfunction

- Disorder of Smooth Muscle

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Measure:** 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

**Time Frame:** one year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* normal pregnancy

Exclusion Criteria:

-

**Healthy Volunteers:** True

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Women after normal birth

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kfar Saba

**Contacts:**

***Contact 1:***

- **Email:** tali.gal@clalit.org.il

- **Name:** Tali Zitman-Gal, PhD

- **Phone:** +972-9-7472401

- **Role:** CONTACT

***Contact 2:***

- **Name:** Tali Zitman-Gal, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Israel

**Facility:** Laboratory of Renal Physiology, Meir Medical Center ,

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Nephrology dept. Meir Medical Center, Kfar Saba , Israel

**Name:** Sydney Benchetrit, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 20089511

**Citation:** Talmor-Barkan Y, Bernheim J, Green J, Benchetrit S, Rashid G. Calcitriol counteracts endothelial cell pro-inflammatory processes in a chronic kidney disease-like environment. J Steroid Biochem Mol Biol. 2011 Mar;124(1-2):19-24. doi: 10.1016/j.jsbmb.2011.01.001. Epub 2011 Jan 12.

**PMID:** 21236342

**Citation:** Talmor-Barkan Y, Rashid G, Weintal I, Green J, Bernheim J, Benchetrit S. Low extracellular Ca2+: a mediator of endothelial inflammation. Nephrol Dial Transplant. 2009 Nov;24(11):3306-12. doi: 10.1093/ndt/gfp354. Epub 2009 Jul 18.

**PMID:** 19617602

**Citation:** Rashid G, Plotkin E, Klein O, Green J, Bernheim J, Benchetrit S. Parathyroid hormone decreases endothelial osteoprotegerin secretion: role of protein kinase A and C. Am J Physiol Renal Physiol. 2009 Jan;296(1):F60-6. doi: 10.1152/ajprenal.00622.2007. Epub 2008 Oct 22.

**PMID:** 18945829

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
