The Effect of Renin Angiotensin System Blockage (RAS) Blockade On PTX3 Levels In Diabetic Patients With Proteinuria
Information source: Gulhane School of Medicine
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Proteinuria; Renin Angiotensin System
Intervention: ramipril (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Gulhane School of Medicine
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.
Clinical Details
Study design: Prevention, Randomized, Single Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Gulhane School of Medicine, Ankara 06018, Turkey
Additional Information
Starting date: January 2006
Ending date: March 2008
Last updated: May 7, 2008
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