NCT00674596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Jan 2006

Typical duration for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2008

Completed
Last Updated

May 8, 2008

Status Verified

May 1, 2008

Enrollment Period

2.2 years

First QC Date

May 6, 2008

Last Update Submit

May 7, 2008

Conditions

Keywords

PTX3, ramipril, endothelial dysfunction1- Diabetic proteinuria2- The aim of this study was to find out whether thebeneficial effects of RAS blockage in diabeticproteinuria has any relation with the alterationof PTX3 levels.

Interventions

ramipril 10 mg/day during 3 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane School of Medicine

Ankara, 06018, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes MellitusProteinuriaAnterior segment mesenchymal dysgenesis

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 8, 2008

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

May 8, 2008

Record last verified: 2008-05

Locations