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ACEIs and ARBs Treatment in Diabetic Patients -Drug Interactions and Adverse Drug Effects

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 January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00437775
First Posted: February 21, 2007
Last Update Posted: February 21, 2007
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:
Assaf-Harofeh Medical Center
  Purpose
Proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients. Hypertenshion treatment and decreasing urine protein excretion, slow down renal deterioration. Treating diabetic ,hypertensive patients with Angiotensin Converting Enzyme inhibitors (ACEi), Angiotensin receptor blockers (ARBs)is common practice. The aim of our work is to examine 1.The prevalence of ACE and ARB treatment in diabetic patients with or without hypertension.2. Adverse drug reactions of ACEi and ARBs alone or in combination.

Condition Phase
Diabetes Mellitus Type 2 Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Angiotensin Converting Enzyme Inhibitors & Angiotensin Receptor Blocker in the Treatment of Type 2 Diabetic Patients Adverse Drug Effects and Drug Interactions- a Survey in an Internal Medicine Department.

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 300
Study Start Date: January 2007
Estimated Study Completion Date: March 2007
Detailed Description:

The study group- men and women with diabetes mellitus type 2,who were hospitalized in the department of internal medicine in Assaf- Harofeh Medical Center.

During hospitalization, data regarding the clinical history,chronic diseases and drugs were collected from the medical files. Blood tests results were recorded during hospitalization .The patients were asked about adverse drug effects.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetic patients admitted to department of Internal Medicine in Assaf Harofeh Medical Center

Exclusion Criteria:

  • Type 1 diabetes mellitus
  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): NCT00437775


Contacts
Contact: Alina Alperovich, B.Pharm 972-547616736 golik@asaf.health.gov.il
Contact: Gabby Elbaz, MD 972-8-977-9240 golik@asaf.health.gov.il

Locations
Israel
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Alina Alperovich, B.Pharm    972-547616736    golik@asaf.health.gov.il   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Director: Ahuva Golik, Assoc. Prof. Sackler School of Medicine, Tel-Aviv University
Principal Investigator: Alina Alperovich, B.Pharm Assaf-Harofeh Medical Center
Study Chair: Lila Akivison, MSc.Pharm Assaf-Harofeh Medical Center
Study Chair: Sofia Berkovitch, MSc. Pharm Assaf-Harofeh Medical Center
Study Chair: Gabby Elbaz, MD Assaf- Hrofech Medical Senter
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00437775     History of Changes
Other Study ID Numbers: 167/06
First Submitted: February 19, 2007
First Posted: February 21, 2007
Last Update Posted: February 21, 2007
Last Verified: January 2007

Keywords provided by Assaf-Harofeh Medical Center:
Diabetes Mellitus type 2
ACE Inhibitors
ARBs
Adverse drug effect

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Drug-Related Side Effects and Adverse Reactions
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Chemically-Induced Disorders
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action