The Effects of Renin Angiotensin System Blockage (RAS), Calcium Channel Blocker and Combined Drugs on TWEAK, PTX3 and FMD Levels in Diabetic Proteinuric Patients With Hypertension
1 other identifier
interventional
105
1 country
1
Brief Summary
Diabetic nephropathy (DN) is the most important complication of diabetes mellitus (DM) and the most common cause of end-stage renal disease (ESRD). Diabetic nephropathy is a clinical syndrome characterized by persistent albuminuria (\> 300 mg/d or \> 200 mcg/min) that is confirmed on at least 2 occasions 3 to 6 months apart, a relentless decline in the glomerular filtration rate (GFR), and elevated arterial blood pressure. In addition to the renal hemodynamic alterations, patients with overt diabetic nephropathy (dipstick-positive proteinuria and decreasing GFR) generally develop systemic hypertension. Hypertension is an adverse factor in all progressive renal diseases and seems especially so in diabetic nephropathy. The deleterious effects of hypertension are likely directed at the vasculature and microvasculature. Use of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blockers (ARBs), strict glycemic control and use of antilipidemic drugs may improve progression of DN. TNF-like weak inducer of apoptosis (TWEAK, TNFSF12) is a member of the TNF superfamily of structurally related cytokines. The human TWEAK gene encodes a 249-amino acid type II transmembrane glycoprotein (30 kD). TWEAK may be expressed as a full-length, membrane-bound protein and as a 156-amino acid, 18-kD soluble protein, (sTWEAK) that results from proteolysis of TWEAK. TWEAK gene is expressed in many tissues, including brain, kidney, heart, arterial wall, monocytes and macrophages. Reduced soluble TNF-like weak inducer of apoptosis (sTWEAK) plasma levels have been reported both in patients with subclinical atherosclerosis and chronic kidney disease (CKD). Long pentraxin 3 (PTX3) is a multimeric inflammatory mediator. Increased serum PTX3 levels have been reported among end-stage renal disease patients. Moreover, PTX3 has been suggested to represent a novel mortality risk factor, and elevated PTX3 levels have been shown to accompany increased albuminuria among patients with chronic kidney disease (CKD). There is no data about the effects of Renin angiotensin system blockage (RAS), calcium channel blocker and combined drugs on TWEAK and PTX3 levels in diabetic proteinuric patients with hypertension. The aim of this study was to find out whether the beneficial effects of RAS blockage, calcium channel blocker and combined drugs in diabetic hypertensive proteinuric patients has any relation with the alteration of TWEAK and PTX3 levels. The investigators searched for the effects of angiotensin II (AII) receptor blocker (Valsartan 160 mg), calcium channel blocker (Amlodipine 10 mg) and AII receptor blocker plus calcium channel blocker (Valsartan 160 mg + Amlodipine 10 mg) on the clinical and laboratory parameters of diabetic hypertensive proteinuric patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 16, 2009
CompletedJune 17, 2009
June 1, 2009
1.2 years
June 15, 2009
June 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow mediated dilatation
12 weeks after
Secondary Outcomes (1)
TWEAK, PTX-3, Systolic Blood Pressure and Diastolic Blood Pressure
12 weeks after
Study Arms (3)
Amlodipine
EXPERIMENTALValsartan
EXPERIMENTALValsartan+Amlodipine
EXPERIMENTALInterventions
calcium channel blocker (Amlodipine 10 mg) during 12 weeks
AII receptor blocker inhibitor (Valsartan 160 mg) during 12 weeks
Eligibility Criteria
You may qualify if:
- CKD stage 1 patients
- Older than 18 years of age
- Type 2 Diabetic patients
- Proteinuria
- Hypertension
You may not qualify if:
- History of coronary artery disease
- Smokers
- Taking statins or renin-angiotensin blockers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
GATA Nephrology
Ankara, 06108, Turkey (Türkiye)
Related Publications (1)
Yilmaz MI, Carrero JJ, Martin-Ventura JL, Sonmez A, Saglam M, Celik T, Yaman H, Yenicesu M, Eyileten T, Moreno JA, Egido J, Blanco-Colio LM. Combined therapy with renin-angiotensin system and calcium channel blockers in type 2 diabetic hypertensive patients with proteinuria: effects on soluble TWEAK, PTX3, and flow-mediated dilation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1174-81. doi: 10.2215/CJN.01110210. Epub 2010 Apr 29.
PMID: 20430947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmut Ilker Yilmaz, MD
GATA
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 15, 2009
First Posted
June 16, 2009
Study Start
February 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 17, 2009
Record last verified: 2009-06