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

NCT ID: NCT03658317

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

cases

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

Group Type ACTIVE_COMPARATOR

renal arterial resistive index

Intervention Type DIAGNOSTIC_TEST

done by dupplex on renal arteries

uric acid level

Intervention Type DIAGNOSTIC_TEST

serum sample for doing the test

serum urea and creatinine

Intervention Type DIAGNOSTIC_TEST

serum samples for doing the test

24 hours urinary proteins

Intervention Type DIAGNOSTIC_TEST

urine collected over 24 hours for doing the test

lipogram

Intervention Type DIAGNOSTIC_TEST

serum sample for doing the test

HbA1c level

Intervention Type DIAGNOSTIC_TEST

serum sample for doing the test

urine analysis

Intervention Type DIAGNOSTIC_TEST

urine sample for doing the test

abdominal ultrasonography

Intervention Type DIAGNOSTIC_TEST

done by the ultrasonography device

controls

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

Group Type ACTIVE_COMPARATOR

renal arterial resistive index

Intervention Type DIAGNOSTIC_TEST

done by dupplex on renal arteries

uric acid level

Intervention Type DIAGNOSTIC_TEST

serum sample for doing the test

serum urea and creatinine

Intervention Type DIAGNOSTIC_TEST

serum samples for doing the test

24 hours urinary proteins

Intervention Type DIAGNOSTIC_TEST

urine collected over 24 hours for doing the test

lipogram

Intervention Type DIAGNOSTIC_TEST

serum sample for doing the test

HbA1c level

Intervention Type DIAGNOSTIC_TEST

serum sample for doing the test

urine analysis

Intervention Type DIAGNOSTIC_TEST

urine sample for doing the test

abdominal ultrasonography

Intervention Type DIAGNOSTIC_TEST

done by the ultrasonography device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

renal arterial resistive index

done by dupplex on renal arteries

Intervention Type DIAGNOSTIC_TEST

uric acid level

serum sample for doing the test

Intervention Type DIAGNOSTIC_TEST

serum urea and creatinine

serum samples for doing the test

Intervention Type DIAGNOSTIC_TEST

24 hours urinary proteins

urine collected over 24 hours for doing the test

Intervention Type DIAGNOSTIC_TEST

lipogram

serum sample for doing the test

Intervention Type DIAGNOSTIC_TEST

HbA1c level

serum sample for doing the test

Intervention Type DIAGNOSTIC_TEST

urine analysis

urine sample for doing the test

Intervention Type DIAGNOSTIC_TEST

abdominal ultrasonography

done by the ultrasonography device

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lipid profile

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

radwa awad abd elhafiz ibrahim

doctor ,assisstant lecturer,principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

muhammed A sobh, professor

Role: CONTACT

+201069272662

marwa k khairallah, MD

Role: CONTACT

+201147536066

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18806710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12646425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22982911 (View on PubMed)

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.

Reference Type RESULT
PMID: 27594114 (View on PubMed)

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.

Reference Type RESULT
PMID: 15616252 (View on PubMed)

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.

Reference Type RESULT
PMID: 18805683 (View on PubMed)

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.

Reference Type RESULT
PMID: 25343266 (View on PubMed)

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.

Reference Type RESULT
PMID: 29870167 (View on PubMed)

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

Reference Type RESULT
PMID: 27312444 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RI in diabetic nephropathy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.