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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Rambam Health Care Campus. Recruitment status was Not yet recruiting

First Received on September 14, 2005. Last Updated on 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 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training
Official Title:	ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Blood Pressure Medicines Diabetes Diabetes Type 2

Drug Information available for: Candesartan 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	Not yet recruiting
Haifa, Israel
Contact: Ayelet Raz, MD 972-4-8543072
Sub-Investigator: Ayelet Raz, MD

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

Principal Investigator:

Shlomo Keidar, MD

Rambam Health Care Campus

More Information

No publications provided

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

Keywords provided by Rambam Health Care Campus:

niddm
ace2
NIDDM patients

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Candesartan
Candesartan cilexetil

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2012