NCT03820635

Brief Summary

The study will be conducted at Assiut University Hospital. Eligible subjects will be screened for vascular calcification by Doppler ultrasound examination. A correation between the level of serum Osteopontin (OPN) level and the extent of vascular calcification will be evaluated.

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

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

January 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1.3 years

First QC Date

January 26, 2019

Last Update Submit

January 26, 2019

Conditions

Diabetic NephropathiesVascular Calcification

Outcome Measures

Primary Outcomes (1)

  • correlation coefficient between serum level of osteoponton and the rate of different aspects of vascular affection as discussed previously

    the correlation coefficient

    6 months

Study Arms (2)

Calcified

those with evidence of vascular calcification

Diagnostic Test: Osteopontin (OPN)

Non-calcified

those with no evidence of vascular calcification

Diagnostic Test: Osteopontin (OPN)

Interventions

Osteopontin (OPN)DIAGNOSTIC_TEST

the serum level of Osteopontin (OPN) will be measured in the subject's blood sample

CalcifiedNon-calcified

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all patients diagnosed with diabetic nephropathies

You may qualify if:

  • adult patients diagnosed clinically as diabetic nephropathy within 5 years

You may not qualify if:

  • patients with any previous macrovascular complication: coronary heart disease, cerebrovascular stroke, peripheral ischaemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Diabetic NephropathiesVascular Calcification

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesCalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

January 26, 2019

First Posted

January 29, 2019

Study Start

March 1, 2019

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

January 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)