NCT01458158

Brief Summary

The purpose of this study is to determine whether matrix metalloproteinases are associated with atherosclerosis in the different stages of chronic kidney disease.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

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

First Submitted

Initial submission to the registry

September 30, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

4.6 years

First QC Date

September 30, 2011

Last Update Submit

February 20, 2015

Conditions

Keywords

Gelatinaseskidney diseasediabetes mellitus type 2

Outcome Measures

Primary Outcomes (1)

  • 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.

    two years

Secondary Outcomes (1)

  • Matrix metalloproteinases and atherosclerosis associated with pro-inflammatory and oxidative stress markers in chronic kidney disease

    two years

Study Arms (3)

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

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from University Hospital AHEPA

You may qualify if:

  • Chronic kidney disease
  • Diabetes mellitus type 2

You may not qualify if:

  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AHEPA University Hospital, Medical School of Aristotle University of Thessaloniki

Thessaloniki, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and vessels

MeSH Terms

Conditions

Diabetic NephropathiesKidney DiseasesDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Grigorios G. Dimas, MD

    AHEPA University Hospital,Medical School of Aristotle University of Thessaloniki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grigorios G. Dimas

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor/PhD Candidate

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 24, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations