Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease

NCT03621384 | Completed

• 1 other identifier: 756/UN2.F1/ETIK/2014
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Diabetic kidney disease (DKD), as one of chronic complication of type 2 diabetes mellitus, is common cause of end stage renal disease (ESRD). Vitamin D deficiency is known as one of DKD risk factors. Recent studies on association between vitamin D deficiency and DKD had shown conflicting results. It may be due to vitamin D receptor gene polymorphisms, which is affected by BsmI, Cdx2, ApaI, FokI, and TaqI gene. The investigators conducted cross-sectional study to investigate association between BsmI polymorphisms in vitamin D receptor gene with diabetic kidney disease Hypothesis: BsmI polymorphisms in vitamin D receptor gene is associated with diabetic kidney disease (DKD)

Conditions

Diabetic Kidney Disease

Keywords

BsmI; Diabetic kidney disease; Polymorphisms; Vitamin D receptor gene

Outcome Measures

Primary Outcomes (1)

• Association between BsmI Polymorphisms in Vitamin D Receptor Gene and Diabetic Kidney Disease

  This study investigated association between BsmI polymorphisms in vitamin D receptor gene with diabetic kidney disease

  1 month

Study Arms (2)

Bb Genotype

Subjects with Bb genotype of BsmI polymorphisms in vitamin D receptor gene

bb Genotype

Subjects with bb genotype of BsmI polymorphisms in vitamin D receptor gene

Eligibility Criteria

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

Study Population

Target population: type 2 diabetes mellitus patients who live in Indonesia Accessible population: type 2 diabetes mellitus patients who visit internal medicine outpatient clinic of dr. Cipto Mangunkusumo Hospital Sample: accessible population which meet study criteria

You may qualify if:

• Type 2 diabetes mellitus patient
• Indonesian-Malay race
• Had signed the informed consent

You may not qualify if:

• Urinary tract infection
• Pregnant patient
• Fever
• In menstrual period
• Had undergone hemodialysis or peritoneal dialysis
• Had used non steroid antiinflammatory drugs (NSAIDs)
• Postexercise

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

dr. Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (18)

• Perhimpunan Nefrologi Indonesia. Report of Indonesian Renal Registry. Jakarta; 2011.

  RESULT

• Ramachandran A, Snehalatha C, Shetty AS, Nanditha A. Trends in prevalence of diabetes in Asian countries. World J Diabetes. 2012 Jun 15;3(6):110-7. doi: 10.4239/wjd.v3.i6.110.

  PMID: 22737281 RESULT

• Zhao HL, Thomas GN, Leung W, Tomlinson B, Hsu YH, Chan P. An update on the management of nephropathy in type 2 diabetes. J Chin Med Assoc. 2003 Nov;66(11):627-36.

  PMID: 14768849 RESULT

• Tseng CH. Lipid abnormalities associated with urinary albumin excretion rate in Taiwanese type 2 diabetic patients. Kidney Int. 2005 Apr;67(4):1547-53. doi: 10.1111/j.1523-1755.2005.00235.x.

  PMID: 15780110 RESULT

• Vedovato M, Lepore G, Coracina A, Dodesini AR, Jori E, Tiengo A, Del Prato S, Trevisan R. Effect of sodium intake on blood pressure and albuminuria in Type 2 diabetic patients: the role of insulin resistance. Diabetologia. 2004 Feb;47(2):300-3. doi: 10.1007/s00125-003-1303-5. Epub 2003 Dec 24.

  PMID: 14704836 RESULT

• Dullaart RP, Beusekamp BJ, Meijer S, van Doormaal JJ, Sluiter WJ. Long-term effects of protein-restricted diet on albuminuria and renal function in IDDM patients without clinical nephropathy and hypertension. Diabetes Care. 1993 Feb;16(2):483-92. doi: 10.2337/diacare.16.2.483.

  PMID: 8432221 RESULT

• Abbasi MA, Abro A, Sheikh M. Smoking is related to albumin excretion in type 2 diabetes mellitus. Pak J Physiol. 2006;2(2):45-8.

  RESULT

• Koroshi A, Idrizi A. Renoprotective effects of Vitamin D and renin-angiotensin system. Hippokratia. 2011 Oct;15(4):308-11.

  PMID: 24391410 RESULT

• Bid HK, Konwar R, Aggarwal CG, Gautam S, Saxena M, Nayak VL, Banerjee M. Vitamin D receptor (FokI, BsmI and TaqI) gene polymorphisms and type 2 diabetes mellitus: a North Indian study. Indian J Med Sci. 2009 May;63(5):187-94.

  PMID: 19584489 RESULT

• Zhang H, Wang J, Yi B, Zhao Y, Liu Y, Zhang K, Cai X, Sun J, Huang L, Liao Q. BsmI polymorphisms in vitamin D receptor gene are associated with diabetic nephropathy in type 2 diabetes in the Han Chinese population. Gene. 2012 Mar 10;495(2):183-8. doi: 10.1016/j.gene.2011.12.049. Epub 2012 Jan 5.

  PMID: 22245613 RESULT

• Vedralova M, Kotrbova-Kozak A, Zeleznikova V, Zoubkova H, Rychlik I, Cerna M. Polymorphisms in the vitamin D receptor gene and parathyroid hormone gene in the development and progression of diabetes mellitus and its chronic complications, diabetic nephropathy and non-diabetic renal disease. Kidney Blood Press Res. 2012;36(1):1-9. doi: 10.1159/000339021. Epub 2012 Jun 18.

  PMID: 22777106 RESULT

• Dewi K. Penurunan fungsi ginjal pada pasien DM tipe 2 di Poliklinik Endokrin Metabolik RSUPN Cipto Mangunkusumo. University of Indonesia; 2007.

  RESULT

• Indra T. Asosiasi antara status vitamin D (25(OH)D) dengan albuminuria pada pasien diabetes melitus tipe 2. University of Indonesia; 2013.

  RESULT

• Giunti S, Barit D, Cooper ME. Mechanisms of diabetic nephropathy: role of hypertension. Hypertension. 2006 Oct;48(4):519-26. doi: 10.1161/01.HYP.0000240331.32352.0c. Epub 2006 Sep 4. No abstract available.

  PMID: 16952978 RESULT

• Bayliss G, Weinrauch LA, D'Elia JA. Pathophysiology of obesity-related renal dysfunction contributes to diabetic nephropathy. Curr Diab Rep. 2012 Aug;12(4):440-6. doi: 10.1007/s11892-012-0288-1.

  PMID: 22638939 RESULT

• Abbate M, Zoja C, Remuzzi G. How does proteinuria cause progressive renal damage? J Am Soc Nephrol. 2006 Nov;17(11):2974-84. doi: 10.1681/ASN.2006040377. Epub 2006 Oct 11.

  PMID: 17035611 RESULT

• Nosratabadi R, Arababadi MK, Salehabad VA, Shamsizadeh A, Mahmoodi M, Sayadi AR, Kennedy D. Polymorphisms within exon 9 but not intron 8 of the vitamin D receptor are associated with the nephropathic complication of type-2 diabetes. Int J Immunogenet. 2010 Dec;37(6):493-7. doi: 10.1111/j.1744-313X.2010.00953.x. Epub 2010 Aug 19.

  PMID: 20727043 RESULT

• Inassi J, Vijayalakshmy R. Role of duration of diabetes in the development of nephropathy in type 2 diabetic patients. Natl J Med Res. 2013;3(1):8-11.

  RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Urea, creatinine, estimated glomerular filtration rate (eGFR), fasting blood glucose (FBG), 2-hours postprandial blood glucose, HbA1c, total cholesterol, triglyceride, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, BsmI polymorphisms in vitamin D receptor gene

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 Officials

• Pringgodigdo Nugroho, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Suhardjono, Prof., MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Aida Lydia, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Kuntjoro Harimurti, MD, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Dekta Filantropi Esa, MD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dialysis Unit, Dr Cipto Mangunkusumo General Hospital

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: August 8, 2018
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

ID (1)