Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy
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| ClinicalTrials.gov Identifier: NCT03658317 |
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Recruitment Status : Unknown
Verified September 2018 by radwa awad abd elhafiz ibrahim, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 14, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Nephropathy | Diagnostic Test: renal arterial resistive index Diagnostic Test: uric acid level Diagnostic Test: serum urea and creatinine Diagnostic Test: 24 hours urinary proteins Diagnostic Test: lipogram Diagnostic Test: HbA1c level Diagnostic Test: urine analysis Diagnostic Test: abdominal ultrasonography | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 150 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Renal Resisitive Index as an Indicator of the Progression of Diabetic Nephropathy |
| Estimated Study Start Date : | September 2018 |
| Estimated Primary Completion Date : | March 2019 |
| Estimated Study Completion Date : | September 2019 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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
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Diagnostic Test: renal arterial resistive index
done by dupplex on renal arteries Diagnostic Test: uric acid level serum sample for doing the test Diagnostic Test: serum urea and creatinine serum samples for doing the test Diagnostic Test: 24 hours urinary proteins urine collected over 24 hours for doing the test Diagnostic Test: lipogram serum sample for doing the test
Other Name: lipid profile Diagnostic Test: HbA1c level serum sample for doing the test Diagnostic Test: urine analysis urine sample for doing the test Diagnostic Test: abdominal ultrasonography done by the ultrasonography device |
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Active Comparator: 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
|
Diagnostic Test: renal arterial resistive index
done by dupplex on renal arteries Diagnostic Test: uric acid level serum sample for doing the test Diagnostic Test: serum urea and creatinine serum samples for doing the test Diagnostic Test: 24 hours urinary proteins urine collected over 24 hours for doing the test Diagnostic Test: lipogram serum sample for doing the test
Other Name: lipid profile Diagnostic Test: HbA1c level serum sample for doing the test Diagnostic Test: urine analysis urine sample for doing the test Diagnostic Test: abdominal ultrasonography done by the ultrasonography device |
- renal resistive index [ Time Frame: once(1day) ]calculated by the renal dupplex
- stage of diabetic nephropathy [ Time Frame: once(1day) ]assessed by the proteinuria level
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658317
| Contact: muhammed A sobh, professor | +201069272662 | muhammed.sobh@yahoo.com | |
| Contact: marwa k khairallah, MD | +201147536066 | marwa.kamal82@hotmail.com |
Other Publications:
| Responsible Party: | radwa awad abd elhafiz ibrahim, doctor ,assisstant lecturer,principle investigator, Assiut University |
| ClinicalTrials.gov Identifier: | NCT03658317 |
| Other Study ID Numbers: |
RI in diabetic nephropathy |
| First Posted: | September 5, 2018 Key Record Dates |
| Last Update Posted: | September 14, 2018 |
| Last Verified: | September 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Kidney Diseases Diabetic Nephropathies Urologic Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Uric Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |