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

Diabetic Nephropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03284996
• Other study ID #: DUDN
• Status: Not yet recruiting
• Phase: N/A
• First received: September 14, 2017
• Last updated: September 14, 2017
• Start date: October 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2017
• Source: Assiut University
• Contact: Hassan Ibrahim Megally, Professor
• Phone: 00201006209845
• Email: hasanibrahim48[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 1, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 1. patients with known history of renal disease or any systemic diseases with renal complications.

2. Serum creatinine >1.2 mg/dl

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Device:
• Doppler ultrasonography
Examination of the whole cases & controls by doppler ultrasound to measure renal resistive index.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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