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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192803
First Posted: September 19, 2005
Last Update Posted: February 23, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rambam Health Care Campus
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • ACE and ACE2 activities in monocytes

Estimated Enrollment: 20
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00192803     History of Changes
Other Study ID Numbers: ACE2.CTIL
First Submitted: September 14, 2005
First Posted: September 19, 2005
Last Update Posted: February 23, 2006
Last Verified: September 2005

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
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action