NCT03284996

Brief Summary

Doppler sonography provides an easily applicable, non-invasive, and well-established method for investigating renal morphologic characteristics and measuring vascular resistance in the renal parenchyma. Doppler are of strategic importance in providing qualitative and quantitative information about the renal vasculature, which can be obtained through the assessment of the resistive index.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

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 14, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

1.6 years

First QC Date

September 14, 2017

Last Update Submit

September 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography

    Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography

    2 years

Interventions

Examination of the whole cases \& controls by doppler ultrasound to measure renal resistive index.

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study was designed as a single-center case control study in which we'll evaluate intra-renal hemodynamic changes with Doppler sonography in diabetic patients in comparison to non-diabetic controls, by studying 80 cases, 40 cases of patients with type 2 diabetes mellitus from the diabetes \& nephrology outpatient clinic in Assiut University Hospital (group A) and 40 age-matched healthy adults served as a control group (group B).

You may qualify if:

  • \. Type 2 diabetic patients. 2. Serum creatinine \<1.2 mg/dl

You may not qualify if:

  • \- 1. patients with known history of renal disease or any systemic diseases with renal complications.
  • \. Serum creatinine \>1.2 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.

  • Tublin ME, Bude RO, Platt JF. Review. The resistive index in renal Doppler sonography: where do we stand? AJR Am J Roentgenol. 2003 Apr;180(4):885-92. doi: 10.2214/ajr.180.4.1800885. No abstract available.

  • Tang SC, Chan GC, Lai KN. Recent advances in managing and understanding diabetic nephropathy. F1000Res. 2016 May 31;5:F1000 Faculty Rev-1044. doi: 10.12688/f1000research.7693.1. eCollection 2016.

  • Mancini M, Masulli M, Liuzzi R, Mainenti PP, Ragucci M, Maurea S, Riccardi G, Vaccaro O. Renal duplex sonographic evaluation of type 2 diabetic patients. J Ultrasound Med. 2013 Jun;32(6):1033-40. doi: 10.7863/ultra.32.6.1033.

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Hassan Ibrahim Megally, Professor

CONTACT

Abolhassan Hasseeb Mohamed, Lecturer

CONTACT

Study Design

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

Study Record Dates

First Submitted

September 14, 2017

First Posted

September 15, 2017

Study Start

October 1, 2017

Primary Completion

April 30, 2019

Study Completion

September 1, 2019

Last Updated

September 15, 2017

Record last verified: 2017-09