ACEIs and ARBs Treatment in Diabetic Patients -Drug Inter... | NCT00437775

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

NCT00437775

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Feb 21, 2007Estimated

Enrollment

300

Phase

Not provided

Conditions

Diabetes Mellitus Type 2

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Mar 2007

First Submitted Date

Feb 19, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2007

Last Update Posted Date

Feb 21, 2007Estimated

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Type 1 diabetes mellitus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alina Alperovich, B.Pharm	Contact	972-547616736		golik@asaf.health.gov.il
Gabby Elbaz, MD	Contact	972-8-977-9240		golik@asaf.health.gov.il

Overall Officials

Name	Affiliation	Role
Ahuva Golik, Assoc. Prof.	Sackler School of Medicine, Tel-Aviv University	Study Director
Alina Alperovich, B.Pharm	Assaf-Harofeh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofeh Medical Center	Recruiting	Ẕerifin		70300	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17003295	Result	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. doi: 10.2337/dc06-0570.
16792436	Result	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. doi: 10.18553/jmcp.2006.12.4.303.

ID	Term
D003924	Diabetes Mellitus, Type 2
D064420	Drug-Related Side Effects and Adverse Reactions

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases