NCT01215994

Brief Summary

The purpose of the present study is to evaluate bias, precision and accuracy of new cystatin C and creatinine based equations for GFR estimation compared with 51Cr-EDTA (chromium-51 labeled ethylenediamine tetraacetic acid) measured GFR in patients with diabetes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 7, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 21, 2015

Status Verified

April 1, 2015

Enrollment Period

7 years

First QC Date

August 30, 2010

Last Update Submit

April 19, 2015

Conditions

Diabetes MellitusDiabetic Nephropathy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

diabetic patients treated in the primary care clinic

You may qualify if:

  • Type 2 and type 1 diabetes mellitus

You may not qualify if:

  • Patients with other type diabetes: gestational, exocrine pancreatic defects, endocrinopathies, drugs
  • Patients with end-stage renal disease, cardiac failure, hepatic failure, malignancies, immunosuppression, pregnant, diabetic ketoacidosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital of Thessaloniki

Thessaloniki, 54636, Greece

RECRUITING

Related Publications (1)

  • Iliadis F, Didangelos T, Ntemka A, Makedou A, Moralidis E, Gotzamani-Psarakou A, Kouloukourgiotou T, Grekas D. Glomerular filtration rate estimation in patients with type 2 diabetes: creatinine- or cystatin C-based equations? Diabetologia. 2011 Dec;54(12):2987-94. doi: 10.1007/s00125-011-2307-1. Epub 2011 Sep 23.

    PMID: 21947381DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine

MeSH Terms

Conditions

Diabetes MellitusDiabetic Nephropathies

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes Complications

Study Officials

  • Dimitrios Grekas, PhD, MD

    Aristotle University of Thessaloniki, Greece

    STUDY CHAIR

Central Study Contacts

Fotios Iliadis, MD, PhD

CONTACT

2310993472iliadis@med.auth.gr

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, ASSISTANT PROFESSOR

Study Record Dates

First Submitted

August 30, 2010

First Posted

October 7, 2010

Study Start

March 1, 2009

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 21, 2015

Record last verified: 2015-04

Locations

GR(1)