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

This study is not yet open for participant recruitment.

Verified by Rambam Health Care Campus, September 2005

First Received: September 14, 2005 Last Updated: February 22, 2006 History of Changes

Sponsor:	Rambam Health Care Campus
Information provided by:	Rambam Health Care Campus
ClinicalTrials.gov Identifier:	NCT00192803

Purpose

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.

Condition	Intervention	Phase
NIDDM	Drug: candesartan	Phase IV

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Pharmacodynamics Study
Official Title:	ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs

Resource links provided by NLM:

MedlinePlus related topics: Blood Pressure Medicines Diabetes

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:

ACE and ACE2 activities in monocytes

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192803

Contacts

Contact: Shlomo Keidar, MD

97248542518

skeidar@rambam.health.gov.il

Locations

Israel
Internal Ward "A", Rambam Medical Center
Haifa, Israel

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:

Shlomo Keidar, MD

Rambam Health Care Campus

More Information

No publications provided

Study ID Numbers:	ACE2.CTIL
Study First Received:	September 14, 2005
Last Updated:	February 22, 2006
ClinicalTrials.gov Identifier:	NCT00192803 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:

niddm
ace2
NIDDM patients

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Candesartan
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010