NCT01703234

Brief Summary

There is no data about the effects of Renin angiotensin system blockage (RAS) on FGF23 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 FGF-23 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
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2008

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, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

October 4, 2012

Last Update Submit

October 6, 2012

Conditions

ProteinuriaDiabetic NephropathyChronic Kidney Disease

Keywords

FGF-23 , ramipril, endothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Flow Mediated Dilatation

Secondary Outcomes (1)

  • FGF-23

Study Arms (1)

Ramipril

EXPERIMENTAL
Drug: Ramipril

Interventions

RamiprilDRUG

ramipril 10 mg/day during 3 months

Ramipril

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, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ProteinuriaDiabetic NephropathiesRenal Insufficiency, Chronic

Interventions

Ramipril

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesRenal InsufficiencyChronic DiseaseDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

October 4, 2012

First Posted

October 10, 2012

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

TU(1)