search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Nephropathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 1, 2018
    Last Updated
    September 12, 2018
    Sponsor
    Assiut University
    search

    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