Non Diabetic Causes of Chronic Kidney Disease in Type 2 Diabetic Patients

NCT05021705 | Completed

• 1 other identifier: Non diabetic kidney disease
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determination of the possible causes of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus with an atypical presentations of renal disease for proper management and thus improving renal outcome.

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• renal biopsy

  The preferred site for renal biopsy was the lateral aspect of the lower pole of the left kidney under ultrasound guidance with the patient in the prone position and local anesthesia was used. An automated biopsy gun and a 16 gauge needle was used to ensure the biopsy sample contained a minimum of ten glomeruli. After biopsy compression on site of biopsy was done and strict follow up for the patient to exclude any complications. No complications were occurred for any patients. Renal biopsy specimens were prepared according to standard methods for light microscopy and immunoperoxidase. Electron microscopy was not routinely performed.

  baseline

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 Diabetic patients

You may qualify if:

• Patients with type 2 diabetes mellitus having proteinuria associated with macroscopic or microscopic haematuria.
• Patients with type 2 diabetes mellitus with nephrotic syndrome appearing in the early stages of DM (less than 10 years of diagnosis) in absence of retinopathy or neuropathy.
• Patients with type 2 diabetes mellitus with unexplained renal failure or rapidly progressive renal dysfunction within few weeks or months.
• Patients with type 2 diabetes mellitus with symptoms and signs suggestive of systemic disease that may affect the kidney as SLE, vasculitis, multiple myeloma or lymphoma.
• Patients with type 2 diabetes mellitus with rapidly progressive glomerulonephritis.

You may not qualify if:

• Patients with type 1 diabetes mellitus.
• DM with clinically, laboratory or radiologically evident CKD due to either chronic pyelonephritis, polycystic kidney disease or chronic obstructive nephropathy.
• DM with end stage renal disease (ESRD) with bilateral small kidneys.
• Patients with any contraindication to renal biopsy (systemic infections, bleeding tendency, low platelets, decrease prothrombin concentration).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (21)

• Espinel E, Agraz I, Ibernon M, Ramos N, Fort J, Seron D. Renal Biopsy in Type 2 Diabetic Patients. J Clin Med. 2015 May 18;4(5):998-1009. doi: 10.3390/jcm4050998.

  PMID: 26239461 BACKGROUND

• Kramer A, Pippias M, Noordzij M, Stel VS, Afentakis N, Ambuhl PM, Andrusev AM, Fuster EA, Arribas Monzon FE, Asberg A, Barbullushi M, Bonthuis M, Caskey FJ, Castro de la Nuez P, Cernevskis H, des Grottes JM, Garneata L, Golan E, Hemmelder MH, Ioannou K, Jarraya F, Kolesnyk M, Komissarov K, Lassalle M, Macario F, Mahillo-Duran B, Martin de Francisco AL, Palsson R, Pechter U, Resic H, Rutkowski B, Santiuste de Pablos C, Seyahi N, Simic Ogrizovic S, Slon Roblero MF, Spustova V, Stojceva-Taneva O, Traynor J, Massy ZA, Jager KJ. The European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report 2015: a summary. Clin Kidney J. 2018 Feb;11(1):108-122. doi: 10.1093/ckj/sfx149. Epub 2018 Jan 5.

  PMID: 29423210 BACKGROUND

• Lytvyn Y, Bjornstad P, Pun N, Cherney DZ. New and old agents in the management of diabetic nephropathy. Curr Opin Nephrol Hypertens. 2016 May;25(3):232-9. doi: 10.1097/MNH.0000000000000214.

  PMID: 26890303 BACKGROUND

• Kramer HJ, Nguyen QD, Curhan G, Hsu CY. Renal insufficiency in the absence of albuminuria and retinopathy among adults with type 2 diabetes mellitus. JAMA. 2003 Jun 25;289(24):3273-7. doi: 10.1001/jama.289.24.3273.

  PMID: 12824208 BACKGROUND

• KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.

  PMID: 17276798 BACKGROUND

• Yuan CM, Nee R, Ceckowski KA, Knight KR, Abbott KC. Diabetic nephropathy as the cause of end-stage kidney disease reported on the medical evidence form CMS2728 at a single center. Clin Kidney J. 2017 Apr;10(2):257-262. doi: 10.1093/ckj/sfw112. Epub 2016 Dec 22.

  PMID: 28396744 BACKGROUND

• Bermejo S, Soler MJ, Gimeno J, Barrios C, Rodriguez E, Mojal S, Pascual J. Predictive factors for non-diabetic nephropathy in diabetic patients. The utility of renal biopsy. Nefrologia. 2016 Sep-Oct;36(5):535-544. doi: 10.1016/j.nefro.2016.06.006. Epub 2016 Aug 11. English, Spanish.

  PMID: 27523263 BACKGROUND

• Fiorentino M, Bolignano D, Tesar V, Pisano A, Van Biesen W, D'Arrigo G, Tripepi G, Gesualdo L; ERA-EDTA Immunonephrology Working Group. Renal Biopsy in 2015--From Epidemiology to Evidence-Based Indications. Am J Nephrol. 2016;43(1):1-19. doi: 10.1159/000444026. Epub 2016 Feb 5.

  PMID: 26844777 BACKGROUND

• Sharma SG, Bomback AS, Radhakrishnan J, Herlitz LC, Stokes MB, Markowitz GS, D'Agati VD. The modern spectrum of renal biopsy findings in patients with diabetes. Clin J Am Soc Nephrol. 2013 Oct;8(10):1718-24. doi: 10.2215/CJN.02510213. Epub 2013 Jul 25.

  PMID: 23886566 BACKGROUND

• Bi H, Chen N, Ling G, Yuan S, Huang G, Liu R. Nondiabetic renal disease in type 2 diabetic patients: a review of our experience in 220 cases. Ren Fail. 2011;33(1):26-30. doi: 10.3109/0886022X.2010.536292.

  PMID: 21219202 BACKGROUND

• Byun JM, Lee CH, Lee SR, Moon JY, Lee SH, Lee TW, Ihm CG, Jeong KH. Renal outcomes and clinical course of nondiabetic renal diseases in patients with type 2 diabetes. Korean J Intern Med. 2013 Sep;28(5):565-72. doi: 10.3904/kjim.2013.28.5.565. Epub 2013 Aug 14.

  PMID: 24009452 BACKGROUND

• Chong YB, Keng TC, Tan LP, Ng KP, Kong WY, Wong CM, Cheah PL, Looi LM, Tan SY. Clinical predictors of non-diabetic renal disease and role of renal biopsy in diabetic patients with renal involvement: a single centre review. Ren Fail. 2012;34(3):323-8. doi: 10.3109/0886022X.2011.647302. Epub 2012 Jan 17.

  PMID: 22250665 BACKGROUND

• Liu MY, Chen XM, Sun XF, Zhou JH, Zhang XG, Zhu HY, Chen YZ, Liu SW, Wei RB, Tang L, Cai GY, Zhang L, Bai XY. Validation of a differential diagnostic model of diabetic nephropathy and non-diabetic renal diseases and the establishment of a new diagnostic model. J Diabetes. 2014 Nov;6(6):519-26. doi: 10.1111/1753-0407.12150. Epub 2014 Apr 25.

  PMID: 24645648 BACKGROUND

• Wilfred DC, Mysorekar VV, Venkataramana RS, Eshwarappa M, Subramanyan R. Nondiabetic Renal Disease in type 2 Diabetes Mellitus Patients: A Clinicopathological Study. J Lab Physicians. 2013 Jul;5(2):94-9. doi: 10.4103/0974-2727.119850.

  PMID: 24701101 BACKGROUND

• Chang TI, Park JT, Kim JK, Kim SJ, Oh HJ, Yoo DE, Han SH, Yoo TH, Kang SW. Renal outcomes in patients with type 2 diabetes with or without coexisting non-diabetic renal disease. Diabetes Res Clin Pract. 2011 May;92(2):198-204. doi: 10.1016/j.diabres.2011.01.017. Epub 2011 Feb 12.

  PMID: 21320734 BACKGROUND

• Wong TY, Choi PC, Szeto CC, To KF, Tang NL, Chan AW, Li PK, Lai FM. Renal outcome in type 2 diabetic patients with or without coexisting nondiabetic nephropathies. Diabetes Care. 2002 May;25(5):900-5. doi: 10.2337/diacare.25.5.900.

  PMID: 11978688 BACKGROUND

• Soleymanian T, Hamid G, Arefi M, Najafi I, Ganji MR, Amini M, Hakemi M, Tehrani MR, Larijani B. Non-diabetic renal disease with or without diabetic nephropathy in type 2 diabetes: clinical predictors and outcome. Ren Fail. 2015 May;37(4):572-5. doi: 10.3109/0886022X.2015.1007804. Epub 2015 Feb 16.

  PMID: 25682971 BACKGROUND

• Robles NR, Villa J, Gallego RH. Non-Proteinuric Diabetic Nephropathy. J Clin Med. 2015 Sep 7;4(9):1761-73. doi: 10.3390/jcm4091761.

  PMID: 26371050 BACKGROUND

• Anguiano L, Riera M, Pascual J, Soler MJ. Endothelin Blockade in Diabetic Kidney Disease. J Clin Med. 2015 May 25;4(6):1171-92. doi: 10.3390/jcm4061171.

  PMID: 26239552 BACKGROUND

• Fioretto P, Mauer M. Histopathology of diabetic nephropathy. Semin Nephrol. 2007 Mar;27(2):195-207. doi: 10.1016/j.semnephrol.2007.01.012.

  PMID: 17418688 BACKGROUND

• Tervaert TW, Mooyaart AL, Amann K, Cohen AH, Cook HT, Drachenberg CB, Ferrario F, Fogo AB, Haas M, de Heer E, Joh K, Noel LH, Radhakrishnan J, Seshan SV, Bajema IM, Bruijn JA; Renal Pathology Society. Pathologic classification of diabetic nephropathy. J Am Soc Nephrol. 2010 Apr;21(4):556-63. doi: 10.1681/ASN.2010010010. Epub 2010 Feb 18.

  PMID: 20167701 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: January 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: May 1, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share