Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients
Primary Purpose
Hypertension, Diabetes Mellitus Type 2
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
N-acetylcystein(drug)
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertension
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
Sites / Locations
Outcomes
Primary Outcome Measures
endothelial function
Secondary Outcome Measures
blood pressure and glycemic control
Full Information
NCT ID
NCT00337038
First Posted
June 14, 2006
Last Updated
June 21, 2012
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00337038
Brief Title
Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus Type 2
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
N-acetylcystein(drug)
Other Intervention Name(s)
siran
Intervention Description
p.O t.Siran 200mg x1 during one weak
Primary Outcome Measure Information:
Title
endothelial function
Time Frame
half of year
Secondary Outcome Measure Information:
Title
blood pressure and glycemic control
Time Frame
half of year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester Paran, MD
Organizational Affiliation
Hypertension Clinic of Soroka University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ester Paran, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Endothelial Function as a Marker for Blood Pressure Control Among Hypertensive Diabetic Patients
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