Estimation of Glomerular Filtration Rate (GFR) in Patient... | NCT01215994

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

NCT01215994

Sponsor

AHEPA University Hospital

Status

Unknown status

Last Update Posted

Apr 21, 2015Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Diabetes Mellitus
Diabetic Nephropathy

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Aug 30, 2010

First Submission Date that Met QC Criteria

Oct 6, 2010

First Posted Date

Oct 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2015

Last Update Posted Date

Apr 21, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fotios Iliadis, MD, ASSISTANT PROFESSOR, AHEPA University HospitalPrincipal Investigator

Lead Sponsor

AHEPA University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

600Estimated

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

diabetic patients treated in the primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fotios Iliadis, MD, PhD	Contact	2310993472	0030	iliadis@med.auth.gr

Overall Officials

Name	Affiliation	Role
Dimitrios Grekas, PhD, MD	Aristotle University of Thessaloniki, Greece	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AHEPA University Hospital of Thessaloniki	Recruiting	Thessaloniki		54636	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21947381	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D003928	Diabetic Nephropathies

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases