Endothelial DysfunctionNCT01423279
The Effect of a Diabetic- and a Kidney-like Environment on Gene and Protein Expression in Cultured EC and SMC
An observational study of Endothelial Dysfunction and Disorder of Smooth Muscle, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Disorder of Smooth Muscle
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women after normal birth
Who may be able to join
- normal pregnancy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Laboratory of Renal Physiology, Meir Medical Center ,
Kfar Saba
Tali Zitman-Gal, PhD, +972-9-7472401, tali.gal@clalit.org.il
Tali Zitman-Gal, PhD
About this study
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
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.
Read the detailed description
Isolation and culturing of endothelial and smooth muscle muscles for academic research
- Conditions
- Endothelial Dysfunction, Disorder of Smooth Muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startFeb 2013
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sydney Benchetrit, MD, Study director, Nephrology dept. Meir Medical Center, Kfar Saba , Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423279
- Sponsor's protocol ID
- MMC11-0074CTIL
- Other IDs
- 0074-11-MMC
- Status last verified
- Aug 2021
- First submitted
- 24 Aug 2011
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20089511Talmor-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.
PubMed 21236342Talmor-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.
PubMed 19617602Rashid 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.
PubMed 18945829
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01423279
- Acronym / sponsor ID
- MMC11-0074CTIL
- Conditions
- Endothelial Dysfunction, Disorder of Smooth Muscle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women after normal birth
Key inclusion criteria (1 listed)
- normal pregnancy
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 20089511Zitman-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.
- Background: PubMed 21236342Talmor-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.
- Background: PubMed 19617602Talmor-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.
- Background: PubMed 18945829Rashid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laboratory of Renal Physiology, Meir Medical Center ,
Kfar Saba, Israel
Sydney Benchetrit, MD study director
Nephrology dept. Meir Medical Center, Kfar Saba , Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction and Disorder of Smooth Muscle, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423279, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.