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

NIDDM Clinical Trial

Official title:

ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00192803
• Other study ID #: ACE2.CTIL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: February 22, 2006

Study information

• Verified date: September 2005
• Source: Rambam Health Care Campus
• Contact: Shlomo Keidar, MD
• Phone: 97248542518
• Email: skeidar[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• NIDDM

Intervention

Drug:
• candesartan

Locations

Country	Name	City	State
Israel	Internal Ward "A", Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACE and ACE2 activities in monocytes