NIDDMPhase 4NCT00192803
Non-Insulin Dependent Diabetes Mellitus (NIDDM) and Angiotensin Converting Enzyme 2 (ACE2): Diabetic Patients Treated With Antihypertensive Drugs
A Phase 4 study testing candesartan in people with NIDDM, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- NIDDM
- What is being tested?
- candesartan
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Internal Ward "A", Rambam Medical Center
Haifa
Ayelet Raz, MD, 972-4-8543072
Ayelet Raz, MD
About this study
Official title: ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs
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.
- Conditions
- NIDDM
- Being tested
- candesartan
- Keywords
- niddm, ace2, NIDDM patients
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
ACE and ACE2 activities in monocytes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NIDDMStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Shlomo Keidar, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192803
- Sponsor's protocol ID
- ACE2.CTIL
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 23 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs
- ClinicalTrials.gov ID
- NCT00192803
- Acronym / sponsor ID
- ACE2.CTIL
- Conditions
- NIDDM
- Keywords
- niddm, ace2, NIDDM patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- First posted
- 19 Sep 2005 (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.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Non-smokers
- Type II DM diagnosed patients
- Blood pressure < 135/90
- Serum HbA1C > 7%
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| candesartan | Drug | – |
Primary outcome
ACE and ACE2 activities in monocytes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2006.
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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.
Shlomo Keidar, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing candesartan in people with NIDDM, run by Rambam Health Care Campus 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 8 inclusion and 6 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 23 Feb 2006. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shlomo Keidar, MD (97248542518, skeidar@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACE and ACE2 activities in monocytes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2006.