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Non-Insulin Dependent Diabetes Mellitus (NIDDM) and Angiotensin Converting Enzyme 2 (ACE2): Diabetic Patients Treated With Antihypertensive Drugs

Primary Purpose

NIDDM

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

candesartan

About this trial

This is an interventional educational/counseling/training trial for NIDDM focused on measuring niddm, ace2, NIDDM patients

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent Non-smokers Type II DM diagnosed patients Blood pressure < 135/90 Serum HbA1C > 7% Serum creatinine < 1mg% Urine microalbumin < 300 mg/day Body mass index (BMI) < 35 kg/m2 Exclusion Criteria: Insulin-dependent diabetic patients Patient with persistent microalbuminuria Patient with history of severe hypertension Congestive heart failure Patient receiving renin-angiotensin-aldosterone system (RAAS)-related anti-hypertensive medications. Patient with major hepatic disease

Sites / Locations

Internal Ward "A", Rambam Medical Center

Outcomes

Primary Outcome Measures

ACE and ACE2 activities in monocytes

Secondary Outcome Measures

Full Information

NCT ID

NCT00192803

First Posted

September 14, 2005

Last Updated

February 22, 2006

Sponsor

Rambam Health Care Campus

1. Study Identification

Unique Protocol Identification Number

NCT00192803

Brief Title

Non-Insulin Dependent Diabetes Mellitus (NIDDM) and Angiotensin Converting Enzyme 2 (ACE2): Diabetic Patients Treated With Antihypertensive Drugs

Official Title

ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Rambam Health Care Campus

4. Oversight

5. Study Description

Brief Summary

This feasibility study is designed to examine modulation of the relative activities of ACE and ACE2 in diabetic patients following treatment with the angiotensin type 1 receptor (AT1R) antagonist, Candesartan. This study will provide a closer insight to the possible involvement of the renin-angiotensin system (RAS)-related enzymatic components in development or attenuation of vascular pathogenesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NIDDM

Keywords

niddm, ace2, NIDDM patients

7. Study Design

Primary Purpose

Educational/Counseling/Training

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

candesartan

Primary Outcome Measure Information:

Title

ACE and ACE2 activities in monocytes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shlomo Keidar, MD

Phone

97248542518

skeidar@rambam.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shlomo Keidar, MD

Organizational Affiliation

Rambam Health Care Campus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Internal Ward "A", Rambam Medical Center

City

Haifa

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayelet Raz, MD

Phone

972-4-8543072

First Name & Middle Initial & Last Name & Degree

Ayelet Raz, MD

12. IPD Sharing Statement

Learn more about this trial

Non-Insulin Dependent Diabetes Mellitus (NIDDM) and Angiotensin Converting Enzyme 2 (ACE2): Diabetic Patients Treated With Antihypertensive Drugs

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