DiabetesPhase 4NCT00674596
The Effect of Renin Angiotensin System Blockage (RAS) Blockade On PTX3 Levels In Diabetic Patients With Proteinuria
A Phase 4 study testing ramipril in people with Diabetes and Proteinuria, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
Long pentraxin 3 (PTX3) is a recently discovered multimeric inflammatory mediator structurally linked to CRP and serum amyloid P-component. There is no data about the effects of Renin angiotensin system blockage (RAS) on PTX3 levels in diabetic patients with proteinuria. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Proteinuria, Renin Angiotensin System
- What is being tested?
- ramipril
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2006to Mar 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CKD stage 1 patients
- Older than 18 years of age
- Type 2 Diabetic patients
- Proteinuria
Who cannot join
- History of coronary artery disease
- Smokers
- Taking statins or renin-angiotensin blockers
Trial locations and contacts
1 site in 1 country.
About this study
Long pentraxin 3 (PTX3) is a recently discovered multimeric inflammatory mediator structurally linked to CRP and serum amyloid P-component. There is no data about the effects of Renin angiotensin system blockage (RAS) on PTX3 levels in diabetic patients with proteinuria. The aim of this study was to find out whether the beneficial effects of RAS blockage in diabetic proteinuria has any relation with the alteration of PTX3 levels. We searched for the effects of ACE inhibitor ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.
Read the detailed description
The patients who were non-obese (BMI<30kg/m2), non dyslipidemic (total cholesterol <200mg/dl, Triglyceride<150mg/dl), and free of cardiovascular events (negative medical history, negative ECG findings) were investigated for enrollment. CKD stage 1 patients older than 18 years of age and willing to participate to the study were screened. From the 266 patients with established type 2 diabetes mellitus, 141 had proteinuria and/or hypertension (24 h protein excretion 1-2 g/day, systolic blood pressures ≥140mmHg and/or diastolic blood pressures ≥ 90 mmHg, respectively). All cases were first referrals and at the time of the study all were off treatment. Patients with history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 141 screened patients 60 met the study criteria and were included in this study. The duration of proteinuria and diabetic nephropathy after initial diagnosis was not known.
The exclusion criteria were as follows: A)Nephrotic syndrome, B)coronary heart disease (patients with ischemic ST-T alterations and voltage criteria for LVH on electrocardiogram, and with history of revascularization or myocardial infarction), C) elevated liver enzymes (AST or ALT levels ≥ 40U/L) and D) renal failure (serum creatinine levels > 1.3 mg/dl).
In order to evaluate the effect of RAS blockade on plasma PTX3 concentrations, patients with proteinuria were given an ACE inhibitor (ramipril 5 mg/day) for 12 weeks. The effect of RAS blockade on insulin sensitivity and proteinuria was also investigated.
After the intervention period, blood samples were obtained for assay of plasma PTX3 concentrations, HbA1c , and insulin resistance scores (HOMA-IR). Urine samples were also collected over a 24-hour period to determine the degree of proteinuria.
- Conditions
- Diabetes, Proteinuria, Renin Angiotensin System
- Being tested
- ramipril
- Keywords
- PTX3, ramipril, endothelial dysfunction, 1- Diabetic proteinuria, 2- The aim of this study was to find out whether the, beneficial effects of RAS blockage in diabetic, proteinuria has any relation with the alteration, of PTX3 levels.
- Medical subject headings
- Diabetes Mellitus, Proteinuria, Anterior segment mesenchymal dysgenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramiprilDrug
ramipril 10 mg/day during 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674596
- Sponsor's protocol ID
- GATARAM2008
- Status last verified
- May 2008
- First submitted
- 6 May 2008
- Last updated
- 8 May 2008
- Results posted
- No
Publications
Yilmaz MI, Axelsson J, Sonmez A, Carrero JJ, Saglam M, Eyileten T, Caglar K, Kirkpantur A, Celik T, Oguz Y, Vural A, Yenicesu M, Lindholm B, Stenvinkel P. Effect of renin angiotensin system blockade on pentraxin 3 levels in type-2 diabetic patients with proteinuria. Clin J Am Soc Nephrol. 2009 Mar;4(3):535-41. doi: 10.2215/CJN.04330808. Epub 2009 Feb 11.
PubMed 19211665
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Renin Angiotensin System Blockage (RAS) Blockade On PTX3 Levels In Diabetic Patients With Proteinuria
- ClinicalTrials.gov ID
- NCT00674596
- Acronym / sponsor ID
- GATARAM2008
- Conditions
- Diabetes, Proteinuria, Renin Angiotensin System
- Keywords
- PTX3, ramipril, endothelial dysfunction, 1- Diabetic proteinuria, 2- The aim of this study was to find out whether the, beneficial effects of RAS blockage in diabetic, proteinuria has any relation with the alteration, of PTX3 levels.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2008
- Study completion
- Mar 2008
- First posted
- 8 May 2008 (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.
Long pentraxin 3 (PTX3) is a recently discovered multimeric inflammatory mediator structurally linked to CRP and serum amyloid P-component. There is no data about the effects of Renin angiotensin system blockage (RAS) on PTX3 levels in diabetic patients with proteinuria. The aim of this study was to find out whether the beneficial effects of RAS blockage in diabetic proteinuria has any relation with the alteration of PTX3 levels. We searched for the effects of ACE inhibitor ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.
Detailed description
The patients who were non-obese (BMI<30kg/m2), non dyslipidemic (total cholesterol <200mg/dl, Triglyceride<150mg/dl), and free of cardiovascular events (negative medical history, negative ECG findings) were investigated for enrollment. CKD stage 1 patients older than 18 years of age and willing to participate to the study were screened. From the 266 patients with established type 2 diabetes mellitus, 141 had proteinuria and/or hypertension (24 h protein excretion 1-2 g/day, systolic blood pressures ≥140mmHg and/or diastolic blood pressures ≥ 90 mmHg, respectively). All cases were first referrals and at the time of the study all were off treatment. Patients with history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 141 screened patients 60 met the study criteria and were included in this study. The duration of proteinuria and diabetic nephropathy after initial diagnosis was not known.
The exclusion criteria were as follows: A)Nephrotic syndrome, B)coronary heart disease (patients with ischemic ST-T alterations and voltage criteria for LVH on electrocardiogram, and with history of revascularization or myocardial infarction), C) elevated liver enzymes (AST or ALT levels ≥ 40U/L) and D) renal failure (serum creatinine levels > 1.3 mg/dl).
In order to evaluate the effect of RAS blockade on plasma PTX3 concentrations, patients with proteinuria were given an ACE inhibitor (ramipril 5 mg/day) for 12 weeks. The effect of RAS blockade on insulin sensitivity and proteinuria was also investigated.
After the intervention period, blood samples were obtained for assay of plasma PTX3 concentrations, HbA1c , and insulin resistance scores (HOMA-IR). Urine samples were also collected over a 24-hour period to determine the degree of proteinuria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD stage 1 patients
- Older than 18 years of age
- Type 2 Diabetic patients
- Proteinuria
Key exclusion criteria (3 listed)
- History of coronary artery disease
- Smokers
- Taking statins or renin-angiotensin blockers
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 |
|---|---|---|
| ramiprilramipril 10 mg/day during 3 months | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2008.
- Derived from this study: PubMed 19211665Yilmaz MI, Axelsson J, Sonmez A, Carrero JJ, Saglam M, Eyileten T, Caglar K, Kirkpantur A, Celik T, Oguz Y, Vural A, Yenicesu M, Lindholm B, Stenvinkel P. Effect of renin angiotensin system blockade on pentraxin 3 levels in type-2 diabetic patients with proteinuria. Clin J Am Soc Nephrol. 2009 Mar;4(3):535-41. doi: 10.2215/CJN.04330808. Epub 2009 Feb 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ramipril in people with Diabetes and Proteinuria, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 8 May 2008. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00674596, which also lists 1 linked publication.
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 8 May 2008.