Diabetes MellitusNCT01215994
Estimation of Glomerular Filtration Rate (GFR) in Patients With Type 2 Diabetes Mellitus.
An observational study of Diabetes Mellitus and Diabetic Nephropathy, run by AHEPA University Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Diabetic Nephropathy
- How many people
- 600 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2009to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetic patients treated in the primary care clinic
Who may be able to join
- Type 2 and type 1 diabetes mellitus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital of Thessaloniki
Thessaloniki, 54636
Alexandra Ntemka, MD
Fotios Iliadis, PhD, MD
About this study
Official title: Comparative Study of New Formulae of GFR Estimation Based on Creatinine, Cystatin C and Cr51-EDTA.
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.
Read the 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
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startMar 2009
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fotios Iliadis, AHEPA University Hospital
- Investigators
- Dimitrios Grekas, PhD, MD, Study chair, Aristotle University of Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215994
- Sponsor's protocol ID
- AHEPA
- Status last verified
- Apr 2015
- First submitted
- 30 Aug 2010
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21947381
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of New Formulae of GFR Estimation Based on Creatinine, Cystatin C and Cr51-EDTA.
- ClinicalTrials.gov ID
- NCT01215994
- Acronym / sponsor ID
- AHEPA
- Conditions
- Diabetes Mellitus, Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients treated in the primary care clinic
Key inclusion criteria (1 listed)
- Type 2 and type 1 diabetes mellitus
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Derived from this study: PubMed 21947381Iliadis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Grekas, PhD, MD study chair
Aristotle University of Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Diabetic Nephropathy, run by AHEPA University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fotios Iliadis, MD, PhD (2310993472 ext. 0030, iliadis@med.auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01215994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.