Diabetes Mellitus Type 2NCT00437775
ACEIs and ARBs Treatment in Diabetic Patients -Drug Interactions and Adverse Drug Effects
An observational study of Diabetes Mellitus Type 2, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2007to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients admitted to department of Internal Medicine in Assaf Harofeh Medical Center
Who cannot join
- Type 1 diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofeh Medical Center
Tsrifin, 70300
Alina Alperovich, B.Pharm, 972-547616736, golik@asaf.health.gov.il
About this study
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.
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.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes Mellitus type 2, ACE Inhibitors, ARBs, Adverse drug effect
- Medical subject headings
- Diabetes Mellitus, Type 2, Drug-Related Side Effects and Adverse Reactions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Ahuva Golik, Assoc. Prof., Study director, Sackler School of Medicine, Tel-Aviv UniversityAlina Alperovich, B.Pharm, Principal investigator, Assaf-Harofeh Medical CenterLila Akivison, MSc.Pharm, Study chair, Assaf-Harofeh Medical CenterSofia Berkovitch, MSc. Pharm, Study chair, Assaf-Harofeh Medical CenterGabby Elbaz, MD, Study chair, Assaf- Hrofech Medical Senter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437775
- Sponsor's protocol ID
- 167/06
- Status last verified
- Jan 2007
- First submitted
- 19 Feb 2007
- Last updated
- 21 Feb 2007
- Results posted
- No
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. doi: 10.2337/dc06-0570.
PubMed 17003295Andros 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.
PubMed 16792436Burnier 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. doi: 10.1097/01.hjh.0000191244.91314.9d.
PubMed 16331093
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00437775
- Acronym / sponsor ID
- 167/06
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Diabetes Mellitus type 2, ACE Inhibitors, ARBs, Adverse drug effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Jan 2007
- Study completion
- Mar 2007
- First posted
- 21 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetic patients admitted to department of Internal Medicine in Assaf Harofeh Medical Center
Key exclusion criteria (1 listed)
- Type 1 diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2007.
- Results publication: PubMed 17003295Winkelmayer 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.
- Results publication: PubMed 16792436Andros 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.
- Results publication: PubMed 16331093Burnier 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. doi: 10.1097/01.hjh.0000191244.91314.9d.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahuva Golik, Assoc. Prof. study director
Sackler School of Medicine, Tel-Aviv University
Alina Alperovich, B.Pharm principal investigator
Assaf-Harofeh Medical Center
Lila Akivison, MSc.Pharm study chair
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2, run by Assaf-Harofeh Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alina Alperovich, B.Pharm (972-547616736, golik@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00437775, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2007.