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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 because the information has not been verified recently.
Verified September 2005 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192803
First received: September 14, 2005
Last updated: February 22, 2006
Last verified: September 2005
  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:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • ACE and ACE2 activities in monocytes

Estimated Enrollment: 20
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014