NCT00192803

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

February 23, 2006

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

February 22, 2006

Conditions

NIDDM

Keywords

niddmace2NIDDM patients

Outcome Measures

Primary Outcomes (1)

  • ACE and ACE2 activities in monocytes

Interventions

candesartanDRUG

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internal Ward "A", Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

candesartan

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Shlomo Keidar, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shlomo Keidar, MD

CONTACT

97248542518skeidar@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 19, 2005

Last Updated

February 23, 2006

Record last verified: 2005-09

Locations

IL(1)