Endothelial Function as a Marker for Blood Pressure Contr... | NCT00337038

Studies
Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients

NCT00337038

Sponsor

Soroka University Medical Center

Status

Completed

Last Update Posted

Jun 22, 2012Estimated

Enrollment

50Actual

Phase

Early Phase 1

Conditions

Hypertension
Diabetes Mellitus Type 2

Interventions

N-acetylcystein(drug)

Countries

Not provided

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

Jun 2012

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

Jun 2006

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jun 14, 2006

First Submission Date that Met QC Criteria

Jun 14, 2006

First Posted Date

Jun 15, 2006Estimated

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

Jun 21, 2012

Last Update Posted Date

Jun 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valentin Yurkevich, Dr Yurkevich, Soroka University Medical CenterPrincipal Investigator

Lead Sponsor

Soroka University Medical CenterOTHER

Collaborators

Not provided

Description Module

Brief Summary

Our aim is to examine the influence of blood pressure and glycemic control together with N-acetylcystein utilization on the endothelia function of hypertensive diabetic patient.The study population will include 50 diabetic patient with uncontrolled hypertention that will be recruited from the Hypertension Clinic of Soroka University Medical Center.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetylcystein(drug)	Drug	p.O t.Siran 200mg x1 during one weak		siran

Measure	Description	Time Frame
endothelial function		half of year

Measure	Description	Time Frame
blood pressure and glycemic control		half of year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients with uncontrolled hypertension that will be recruited from the Hypertension Clinic of Soroka University Medical Center

Exclusion Criteria:

Pregnancy,secondary hypertention,malignancy or other serious illness

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ester Paran, MD	Hypertension Clinic of Soroka University Medical Center	Principal Investigator
Ester Paran, MD	Soroka University Medical Center	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided