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

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

February 22, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

ACE and ACE2 activities in monocytes

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00192803 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Educational/Counseling/Training, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacodynamics Study

Condition ^ICMJE

NIDDM

Intervention ^ICMJE

Drug: candesartan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Shlomo Keidar, MD

97248542518

skeidar@rambam.health.gov.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00192803

Responsible Party

Study ID Numbers ^ICMJE

ACE2.CTIL

Study Sponsor ^ICMJE

Rambam Health Care Campus

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Shlomo Keidar, MD

Rambam Health Care Campus

Information Provided By

Rambam Health Care Campus

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP