Diabetic NephropathyMMACKDNCT01458158
Matrix Metalloproteinases in Atherosclerosis of Chronic Kidney Disease
An observational study of Diabetic Nephropathy, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
The purpose of this study is to determine whether matrix metalloproteinases are associated with atherosclerosis in the different stages of chronic kidney disease. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy
- How many people
- 300 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2011to May 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from University Hospital AHEPA
Who may be able to join
- Chronic kidney disease
- Diabetes mellitus type 2
Who cannot join
- Malignancy
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
AHEPA University Hospital, Medical School of Aristotle University of Thessaloniki
Thessaloniki
Grigorios G. Dimas, MD
About this study
Official title: The Role of Matrix Metalloproteinases -2 and -9 in Atherosclerosis of Patients With Chronic Kidney Disease
The purpose of this study is to determine whether matrix metalloproteinases are associated with atherosclerosis in the different stages of chronic kidney disease.
Read the detailed description
The purpose of this study is to determine the correlation of matrix metalloproteinases and atherosclerosis of chronic kidney disease. Patients with diabetes mellitus type 2,as a non-inflammatory leading cause of end stage renal failure and patients with chronic glomerulonephritis and similar course of proteinuria,as an inflammatory leading cause of end stage renal failure are enrolled.
- Conditions
- Diabetic Nephropathy
- Keywords
- Gelatinases, kidney disease, diabetes mellitus type 2
- Medical subject headings
- Diabetic Nephropathies, Kidney Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic nephropathy | Diabetic nephropathy in patients with type 2 diabetes | |
| chronic glomerulonephritis | chronic glomerulonephritis in patients without diabetes mellitus | |
| controls | participants without diabetic nephropathy and chronic glomerulonephritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of matrix metalloproteinases with atherosclerosis in patients with chronic kidney disease
Matrix metalloproteinases associated with atherosclerosis in chronic kidney disease;patients with diabetes mellitus type 2 and others with chronic glomerulonephritis.Serum levels of MMPs-2 and -9 are measured by an ELISA system.Intima Media Thickness(IMT) of carotid and femoral arteries is measured with a high resolution ultrasonography.
Measured: two years
Secondary outcomes (1)
Matrix metalloproteinases and atherosclerosis associated with pro-inflammatory and oxidative stress markers in chronic kidney disease
Matrix metalloproteinases associated with atherosclerosis markers,pro-inflammatory markers and markers of oxidative stress in chronic kidney disease
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- AHEPA University Hospital
- Responsible party
- Principal investigator, Grigorios G. DIMAS, Aristotle University Of Thessaloniki
- Investigators
- Grigorios G. Dimas, MD, Principal investigator, AHEPA University Hospital,Medical School of Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458158
- Sponsor's protocol ID
- A13749
- Other IDs
- 31-8-2010
- Acronym
- MMACKD
- Status last verified
- Feb 2015
- First submitted
- 30 Sep 2011
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Matrix Metalloproteinases -2 and -9 in Atherosclerosis of Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01458158
- Acronym / sponsor ID
- MMACKD / A13749
- Conditions
- Diabetic Nephropathy
- Keywords
- Gelatinases, kidney disease, diabetes mellitus type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- AHEPA University Hospital
- Study start
- Oct 2011
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 24 Oct 2011 (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 this study is to determine whether matrix metalloproteinases are associated with atherosclerosis in the different stages of chronic kidney disease.
Detailed description
The purpose of this study is to determine the correlation of matrix metalloproteinases and atherosclerosis of chronic kidney disease. Patients with diabetes mellitus type 2,as a non-inflammatory leading cause of end stage renal failure and patients with chronic glomerulonephritis and similar course of proteinuria,as an inflammatory leading cause of end stage renal failure are enrolled.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic nephropathy | – | –Diabetic nephropathy in patients with type 2 diabetes |
| chronic glomerulonephritis | – | –chronic glomerulonephritis in patients without diabetes mellitus |
| controls | – | –participants without diabetic nephropathy and chronic glomerulonephritis |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from University Hospital AHEPA
Key inclusion criteria (2 listed)
- Chronic kidney disease
- Diabetes mellitus type 2
Key exclusion criteria (1 listed)
- Malignancy
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
Association of matrix metalloproteinases with atherosclerosis in patients with chronic kidney disease
Time frame: two years
Matrix metalloproteinases associated with atherosclerosis in chronic kidney disease;patients with diabetes mellitus type 2 and others with chronic glomerulonephritis.Serum levels of MMPs-2 and -9 are measured by an ELISA system.Intima Media Thickness(IMT) of carotid and femoral arteries is measured with a high resolution ultrasonography.
1 secondary outcome
Matrix metalloproteinases and atherosclerosis associated with pro-inflammatory and oxidative stress markers in chronic kidney disease
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2015.
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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.
Grigorios G. Dimas, MD principal investigator
AHEPA University Hospital,Medical School of Aristotle University of Thessaloniki
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 Diabetic Nephropathy, run by Aristotle University Of Thessaloniki 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 2 inclusion and 1 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 23 Feb 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 Grigorios G. Dimas (+0030 6972321534, gregorydimas@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of matrix metalloproteinases with atherosclerosis in patients with chronic kidney disease (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2015.