Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03658317
• Other study ID #: RI in diabetic nephropathy
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2018
• Est. completion date: September 2019

Study information

• Verified date: September 2018
• Source: Assiut University
• Contact: muhammed A sobh, professor
• Phone: +201069272662
• Email: muhammed.sobh[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

diabetic nephropathy is one of the leading causes of end stage renal disease

Description:

Diabetes mellitus is one of the systemic diseases affecting the kidneys. Diabetic nephropathy is a serious microvascular complication of diabetes mellitus. It is the most important cause of death in type I diabetic patients, of whom 30%-40% eventually develop end-stage renal failure and 40% of type II diabetics are at risk of developing diabetic nephropathy. So, diagnosis of diabetic nephropathy is paramount for the survivability of the diabetic patients not only because of the consequences of renal progression but also because of the strong association with the risk of developing cardiovascular disease Diabetic nephropathy (DN) is defined as persistent proteinuria greater than 500 mg/24 h, or albuminuria greater than 300 mg/24 h.

In the kidney, renal pathological changes leading to diabetic nephropathy are mainly secondary to atherosclerosis of the intra and extra renal arteries together with microangiopathy of the glomerular capillaries, afferent arterioles and efferent arteriole.

Doppler sonography may be a useful complementary test in the evaluation of DN, even in the early stages. Early stage of vascular involvement seems, in fact, to be characterized by functional alterations of endothelial control on vascular tone and wall interaction with circulating cells. Renal Doppler assessment of RI is a reliable, non-invasive evaluation of arterial function and is particularly useful for early diagnosis of vascular involvement.

Increasing evidence suggests that the intra-renal arterial RI, measured by Doppler ultrasound, a well-established technique for the investigation of renal morphology and hemodynamics, predicts the course of renal function in several conditions.

No standard, validated, cut-off to distinguish normal from high RI has been identified to date. RI values between 0.75 and 0.85 have been associated with renal functional impairment in patients with chronic kidney disease and stenosis of the renal artery, and they also predict allograft dysfunction in kidney transplant recipients Little information is available on the use of RI for the identification and prediction of DN in routine clinical practice. It is yet unclear whether RI predicts DN in low-risk patients; also, the correlation between increased intra-renal RI and altered renal hemodynamics remains unclear independent of albuminuria, as also the most appropriate cut-off value The renal arterial resistive index (RI) is a sonographic index to assess for renal arterial disease. It is measured as RI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity Measured at arcuate arteries (at the corticomedullary junction) or interlobar arteries (adjacent to medullary pyramids) intrarenal resistive index (RI) has been reported to be increased in hypertensive subjects with microalbuminuria and limited data is present for diabetic subjects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diabetic patients either type I or type II diabetes mellitus with or without any clinical evidence of diabetic nephropathy

Exclusion Criteria:

• Any disease affecting the cardiovascular system as vasculitis and hypertension Patients with ESRD due to diabetic nephropathy on regular dialysis Patients with nephrolithiasis Patients having any type of glomerulonephritis Patients with renal artery stenosis Renal transplantation recipients patients suffering from polycystic kidney disease or any other structural renal disease.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Diagnostic Test:
• renal arterial resistive index
done by dupplex on renal arteries
• uric acid level
serum sample for doing the test
• serum urea and creatinine
serum samples for doing the test
• 24 hours urinary proteins
urine collected over 24 hours for doing the test
• lipogram
serum sample for doing the test
• HbA1c level
serum sample for doing the test
• urine analysis
urine sample for doing the test
• abdominal ultrasonography
done by the ultrasonography device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (9)

Afsar B, Elsurer R. Increased renal resistive index in type 2 diabetes: Clinical relevance, mechanisms and future directions. Diabetes Metab Syndr. 2017 Oct - Dec;11(4):291-296. doi: 10.1016/j.dsx.2016.08.019. Epub 2016 Aug 30. Review. — View Citation

Gross JL, de Azevedo MJ, Silveiro SP, Canani LH, Caramori ML, Zelmanovitz T. Diabetic nephropathy: diagnosis, prevention, and treatment. Diabetes Care. 2005 Jan;28(1):164-76. Review. — View Citation

Masulli M, Mancini M, Liuzzi R, Daniele S, Mainenti PP, Vergara E, Genovese S, Salvatore M, Vaccaro O. Measurement of the intrarenal arterial resistance index for the identification and prediction of diabetic nephropathy. Nutr Metab Cardiovasc Dis. 2009 J — View Citation

Ozmen ND, Mousa U, Aydin Y, Deren T, Unlu EB. Association of the renal resistive index with microvascular complications in type 2 diabetic subjects. Exp Clin Endocrinol Diabetes. 2015 Feb;123(2):112-7. doi: 10.1055/s-0034-1390448. Epub 2014 Oct 24. — View Citation

Said SM, Nasr SH. Silent diabetic nephropathy. Kidney Int. 2016 Jul;90(1):24-6. doi: 10.1016/j.kint.2016.02.042. — View Citation

Shirin M, Sharif MM, Gurung A, Datta A. Resistive Index of Intrarenal Artery in Evaluation of Diabetic Nephropathy. Bangladesh Med Res Counc Bull. 2015 Dec;41(3):125-130. — View Citation

Steinke JM, Mauer M; International Diabetic Nephropathy Study Group. Lessons learned from studies of the natural history of diabetic nephropathy in young type 1 diabetic patients. Pediatr Endocrinol Rev. 2008 Aug;5 Suppl 4:958-63. 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

Youssef DM, Fawzy FM. Value of renal resistive index as an early marker of diabetic nephropathy in children with type-1 diabetes mellitus. Saudi J Kidney Dis Transpl. 2012 Sep;23(5):985-92. doi: 10.4103/1319-2442.100880. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal resistive index	calculated by the renal dupplex	once(1day)
Secondary	stage of diabetic nephropathy	assessed by the proteinuria level	once(1day)