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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier:

NCT00437775

First received: February 19, 2007

Last updated: February 20, 2007

Last verified: January 2007

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Type 2 Drug Reactions

U.S. FDA Resources

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

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Winkelmayer WC, Zhang Z, Shahinfar S, Cooper ME, Avorn J, Brenner BM. Efficacy and safety of angiotensin II receptor blockade in elderly patients with diabetes. Diabetes Care. 2006 Oct;29(10):2210-7.

Andros V, Egger A, Dua U. Blood pressure goal attainment according to JNC 7 guidelines and utilization of antihypertensive drug therapy in MCO patients with type 1 or type 2 diabetes. J Manag Care Pharm. 2006 May;12(4):303-9.

Burnier M, Zanchi A. Blockade of the renin-angiotensin-aldosterone system: a key therapeutic strategy to reduce renal and cardiovascular events in patients with diabetes. J Hypertens. 2006 Jan;24(1):11-25. Review.

ClinicalTrials.gov Identifier:	NCT00437775 History of Changes
Other Study ID Numbers:	167/06
Study First Received:	February 19, 2007
Last Updated:	February 20, 2007
Health Authority:	Israel: Ministry of Health

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 Toxicity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Poisoning

Substance-Related Disorders
Angiotensin-Converting Enzyme Inhibitors
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013

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