Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
renal arterial resistive index
uric acid level
serum urea and creatinine
24 hours urinary proteins
lipogram
HbA1c level
urine analysis
abdominal ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetic Nephropathy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
cases
controls
Arm Description
laboratory tests including (random blood glucose , serum urea and creatinine , lipogram , serum uric acid , HbA1c , urine analysis , 24 hours urinary proteins ) abdominal ultrasonography dupplex on the renal vessels
laboratory tests including (random blood glucose , serum urea and creatinine , lipogram , serum uric acid , HbA1c , urine analysis , 24 hours urinary proteins ) abdominal ultrasonography dupplex on the renal vessels
Outcomes
Primary Outcome Measures
renal resistive index
calculated by the renal dupplex
Secondary Outcome Measures
stage of diabetic nephropathy
assessed by the proteinuria level
Full Information
NCT ID
NCT03658317
First Posted
September 1, 2018
Last Updated
September 12, 2018
Sponsor
Assiut University
1. Study Identification
Unique Protocol Identification Number
NCT03658317
Brief Title
Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy
Official Title
Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
diabetic nephropathy is one of the leading causes of end stage renal disease
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cases
Arm Type
Active Comparator
Arm Description
laboratory tests including (random blood glucose , serum urea and creatinine , lipogram , serum uric acid , HbA1c , urine analysis , 24 hours urinary proteins ) abdominal ultrasonography dupplex on the renal vessels
Arm Title
controls
Arm Type
Active Comparator
Arm Description
laboratory tests including (random blood glucose , serum urea and creatinine , lipogram , serum uric acid , HbA1c , urine analysis , 24 hours urinary proteins ) abdominal ultrasonography dupplex on the renal vessels
Intervention Type
Diagnostic Test
Intervention Name(s)
renal arterial resistive index
Intervention Description
done by dupplex on renal arteries
Intervention Type
Diagnostic Test
Intervention Name(s)
uric acid level
Intervention Description
serum sample for doing the test
Intervention Type
Diagnostic Test
Intervention Name(s)
serum urea and creatinine
Intervention Description
serum samples for doing the test
Intervention Type
Diagnostic Test
Intervention Name(s)
24 hours urinary proteins
Intervention Description
urine collected over 24 hours for doing the test
Intervention Type
Diagnostic Test
Intervention Name(s)
lipogram
Other Intervention Name(s)
lipid profile
Intervention Description
serum sample for doing the test
Intervention Type
Diagnostic Test
Intervention Name(s)
HbA1c level
Intervention Description
serum sample for doing the test
Intervention Type
Diagnostic Test
Intervention Name(s)
urine analysis
Intervention Description
urine sample for doing the test
Intervention Type
Diagnostic Test
Intervention Name(s)
abdominal ultrasonography
Intervention Description
done by the ultrasonography device
Primary Outcome Measure Information:
Title
renal resistive index
Description
calculated by the renal dupplex
Time Frame
once(1day)
Secondary Outcome Measure Information:
Title
stage of diabetic nephropathy
Description
assessed by the proteinuria level
Time Frame
once(1day)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
muhammed A sobh, professor
Phone
+201069272662
Email
muhammed.sobh@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
marwa k khairallah, MD
Phone
+201147536066
Email
marwa.kamal82@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
18806710
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.
Results Reference
background
PubMed Identifier
12646425
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. doi: 10.2214/ajr.180.4.1800885. No abstract available.
Results Reference
background
PubMed Identifier
22982911
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.
Results Reference
background
PubMed Identifier
27594114
Citation
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.
Results Reference
result
PubMed Identifier
15616252
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. doi: 10.2337/diacare.28.1.164.
Results Reference
result
PubMed Identifier
18805683
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 Jun;19(5):358-64. doi: 10.1016/j.numecd.2008.07.003. Epub 2008 Sep 20.
Results Reference
result
PubMed Identifier
25343266
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.
Results Reference
result
PubMed Identifier
29870167
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. doi: 10.3329/bmrcb.v41i3.29888.
Results Reference
result
PubMed Identifier
27312444
Citation
Said SM, Nasr SH. Silent diabetic nephropathy. Kidney Int. 2016 Jul;90(1):24-6. doi: 10.1016/j.kint.2016.02.042.
Results Reference
result
Learn more about this trial
Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy
We'll reach out to this number within 24 hrs