CClinicalTrials.gg
Status unknownNCT03284996Updated Sep 15, 2017

Doppler Ultrasound in Early Detection of Diabetic Nephropathy Type 2 Diabetes Mellitus.

An observational study in Diabetic Nephropathies, sponsored by Assiut University. Status unknown. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Nephropathy is one of the most common long-term, life-threatening complications causing a high rate of morbidity and mortality among individual patients with type 2 diabetes.

The onset and progression of nephropathy can be delayed by interventions, provided they are instituted early in the course of the disease.

Doppler sonography allows non-invasive method for investigating renal hemodynamics. Renal resistive index measured using Doppler ultrasonography, reflects intra-renal vascular resistance.

Although Doppler sonography clearly does not substitute for renal biopsy, several studies have suggested that it might aid in the management of established renal disease and provide an easily applicable and noninvasive method for investigating renal hemodynamics.

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. It is one of the most sensitive parameters in the study of kidney diseases and allows us to quantify the changes in renal plasma flow . A normal resistive index is below 0.7 in adults and children who are six years of age or older.

02

Conditions studied

03

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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).

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • DeviceDoppler ultrasonography

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

05

What researchers measure

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

    Time frame: 2 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 2970215 ↗
  • 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. PubMed 12646425 ↗
  • 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. PubMed 27303648 ↗
  • 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. PubMed 23716525 ↗
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Registry details

Key details

Study ID
NCT03284996
Lead sponsor
Assiut University
Responsible party
Shery Dawood Yassa (Principal investigator, Assiut University) — Principal investigator
First posted
Sep 15, 2017
Start date
Oct 1, 2017 (estimated)
Primary completion
Apr 30, 2019 (estimated)
Completion
Sep 1, 2019 (estimated)
Last update
Sep 15, 2017

Study contacts

Hassan Ibrahim Megally, Professor
Contact
hasanibrahim48@aun.edu.eg
00201006209845
Abolhassan Hasseeb Mohamed, Lecturer
Contact
abolhasan_96@aun.edu.eg
00201009562059

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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