Estimation of Glomerular Filtration Rate (GFR) in Patients With Type 2 Diabetes Mellitus.

• Conditions: Diabetic Nephropathy; Diabetes Mellitus

• Registration Number: NCT01215994
• Lead Sponsor: AHEPA University Hospital

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.

Detailed Description

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 measured GFR in patients with diabetes.

Additional, we will check which equation detects better the reduction of renal function over the time, in patients with diabetes.

Finally, we will investigate if cystatin C levels can be influenced by factors other than GFR

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-19
• Last Update Posted: 2015-04-21
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Type 2 and type 1 diabetes mellitus

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

AHEPA University Hospital of Thessaloniki; 🇬🇷 Thessaloniki, Greece