NCT03658317

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

September 1, 2018

Last Update Submit

September 12, 2018

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • renal resistive index

    calculated by the renal dupplex

    once(1day)

Secondary Outcomes (1)

  • stage of diabetic nephropathy

    once(1day)

Study Arms (2)

cases

ACTIVE COMPARATOR

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 indexDiagnostic Test: uric acid levelDiagnostic Test: serum urea and creatinineDiagnostic Test: 24 hours urinary proteinsDiagnostic Test: lipogramDiagnostic Test: HbA1c levelDiagnostic Test: urine analysisDiagnostic Test: abdominal ultrasonography

controls

ACTIVE COMPARATOR

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 indexDiagnostic Test: uric acid levelDiagnostic Test: serum urea and creatinineDiagnostic Test: 24 hours urinary proteinsDiagnostic Test: lipogramDiagnostic Test: HbA1c levelDiagnostic Test: urine analysisDiagnostic Test: abdominal ultrasonography

Interventions

renal arterial resistive indexDIAGNOSTIC_TEST

done by dupplex on renal arteries

casescontrols
uric acid levelDIAGNOSTIC_TEST

serum sample for doing the test

casescontrols
serum urea and creatinineDIAGNOSTIC_TEST

serum samples for doing the test

casescontrols
24 hours urinary proteinsDIAGNOSTIC_TEST

urine collected over 24 hours for doing the test

casescontrols
lipogramDIAGNOSTIC_TEST

serum sample for doing the test

Also known as: lipid profile
casescontrols
HbA1c levelDIAGNOSTIC_TEST

serum sample for doing the test

casescontrols
urine analysisDIAGNOSTIC_TEST

urine sample for doing the test

casescontrols
abdominal ultrasonographyDIAGNOSTIC_TEST

done by the ultrasonography device

casescontrols

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 18806710BACKGROUND

  • 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.

    PMID: 12646425BACKGROUND

  • 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.

    PMID: 22982911BACKGROUND

  • 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.

    PMID: 27594114RESULT

  • 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.

    PMID: 15616252RESULT

  • 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.

    PMID: 18805683RESULT

  • 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.

    PMID: 25343266RESULT

  • 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.

    PMID: 29870167RESULT

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

    PMID: 27312444RESULT

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, UrologicalInvestigative Techniques

Central Study Contacts

muhammed A sobh, professor

CONTACT

+201069272662muhammed.sobh@yahoo.com

marwa k khairallah, MD

CONTACT

+201147536066marwa.kamal82@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor ,assisstant lecturer,principle investigator

Study Record Dates

First Submitted

September 1, 2018

First Posted

September 5, 2018

Study Start

September 1, 2018

Primary Completion

March 1, 2019

Study Completion

September 1, 2019

Last Updated

September 14, 2018

Record last verified: 2018-09