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The Effect of Renin Angiotensin System Blockage (RAS) Blockade On PTX3 Levels In Diabetic Patients With Proteinuria

Primary Purpose

Diabetes, Proteinuria, Renin Angiotensin System

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
ramipril
Sponsored by
Gulhane School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring 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.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • CKD stage 1 patients
  • Older than 18 years of age
  • Type 2 Diabetic patients
  • Proteinuria

Exclusion Criteria:

  • History of coronary artery disease
  • Smokers
  • Taking statins or renin-angiotensin blockers

Sites / Locations

  • Gulhane School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2008
Last Updated
May 7, 2008
Sponsor
Gulhane School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00674596
Brief Title
The Effect of Renin Angiotensin System Blockage (RAS) Blockade On PTX3 Levels In Diabetic Patients With Proteinuria
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2008 (undefined)
Study Completion Date
March 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gulhane School of Medicine

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ramipril
Intervention Description
ramipril 10 mg/day during 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: CKD stage 1 patients Older than 18 years of age Type 2 Diabetic patients Proteinuria Exclusion Criteria: History of coronary artery disease Smokers Taking statins or renin-angiotensin blockers
Facility Information:
Facility Name
Gulhane School of Medicine
City
Ankara
ZIP/Postal Code
06018
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
19211665
Citation
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.
Results Reference
derived

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The Effect of Renin Angiotensin System Blockage (RAS) Blockade On PTX3 Levels In Diabetic Patients With Proteinuria

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