Effect of Renin Angiotensin System Blockade on the Fas Antigen (CD95) and Asymmetric Dimethylarginine (ADMA) Levels in Type-2 Diabetic Patients With Proteinuria

NCT00893425 | Completed Phase 4

• 1 other identifier: GATARAMCD9509
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

In recent years, diabetic nephropathy, which may lead to dialysis treatment, is the most prevalent underlying disease of people in developed countries. A wide range of studies have been carried out, from various points of view, to understand the progress of renal dysfunction in diabetic nephropathy. The endogenous nitric oxide synthase (NOS) inhibitor asymmetric dimethylarginine (ADMA) is elevated in patients with chronic kidney disease (CKD) and may have a role in the cardiovascular mortality and morbidity of these patients. In diabetic nephropathy, high ADMA levels were related to progression of diabetic nephropathy. The Fas (CD95) antigen is a cell surface polypeptide belonging to the tumor necrosis factor receptor (TNF-R) family (type I membrane protein) that transduces a death signal after interaction with its ligand. Apoptotic cells are then recognized and removed by phagocytes. Recent studies suggest that, in uremic patients, peripheral blood mononuclear cells undergo accelerated apoptosis and this correlates with Fas levels. There is no data about the effects of Renin angiotensin system blockage (RAS) on CD95 and ADMA 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 ADMA and CD95levels. The investigators searched for the effects of ACE inhibitor ramipril on the clinical and laboratory parameters of diabetic patients with proteinuria.

Conditions

Proteinuria; Diabetic Nephropathy; Chronic Kidney Disease

Keywords

CD95; ADMA; proteinuria; diabetic nephropathy; CD95 and ADMA levels

Outcome Measures

Primary Outcomes (1)

• Flow mediated dilatation

Secondary Outcomes (1)

• ADMA CD95

Interventions

ramipril DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane School of Medicine

Ankara, 06108, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Proteinuria; Diabetic Nephropathies; Renal Insufficiency, Chronic; Autoimmune Lymphoproliferative Syndrome, Type IA

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mahmut I Yilmaz, MD

  Gulhane School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: May 6, 2009
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

TU (1)