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

This study has been completed.
Sponsor:
Information provided by:
Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT00674596
First received: May 6, 2008
Last updated: May 7, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Diabetes
Proteinuria
Renin Angiotensin System
Drug: ramipril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Gulhane School of Medicine:

Estimated Enrollment: 60
Study Start Date: January 2006
Estimated Study Completion Date: March 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ramipril
    ramipril 10 mg/day during 3 months
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00674596

Locations
Turkey
Gulhane School of Medicine
Ankara, Turkey, 06018
Sponsors and Collaborators
Gulhane School of Medicine
  More Information

No publications provided by Gulhane School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00674596     History of Changes
Other Study ID Numbers: GATARAM2008
Study First Received: May 6, 2008
Last Updated: May 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Gulhane School of Medicine:
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.

Additional relevant MeSH terms:
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014