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

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03621384
• Other study ID #: 756/UN2.F1/ETIK/2014
• Status: Completed
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: August 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Description:

Diabetic kidney disease (DKD) is a common cause of end stage renal disease (ESRD). Data from Indonesian Renal Registry (2011) revealed that 25% etiology of patients who underwent hemodialysis is DKD. Risk factors that are associated with DKD include blood glucose control, hypertension, dyslipidemia, duration of diabetes mellitus, high body mass index (BMI), age, sex, ethnicity, vitamin D deficiency, high sodium diet, high protein diet, and smoking.

The roles of vitamin D that are related to kidney are inhibition of renin transcription process, angiotensin II, renal inflammation process, and albumin excretion, prevention of podocytes damage, glomerulosclerosis process, and transformation from kidney epithelial cell into mesenchymal cell. Current studies on association between vitamin D deficiency and DKD had shown conflicting results. It may be related to genetic factor which is vitamin D receptor polymorphisms. The vitamin D receptor polymorphism is affected by Cdx2, ApaI, BsmI, FokI, and TaqI gene, where Asian population is mostly affected by ApaI, FokI, and Cdx2.

Several studies had reported the association between BsmI polymorphisms in vitamin D receptor gene and DKD in various population. Zhang, et al (2012) study revealed the association between BsmI polymorphisms in vitamin D receptor gene and DKD in Han Chinese population, while study from Vedralova, et al (2012) in Caucasian race showed opposite result. However, the association between BsmI polymorphism in vitamin D receptor gene and DKD has not been investigated in Indonesian-Malay race.

This is a cross-sectional study that investigate the association between BsmI polymorphisms in vitamin D receptor gene and DKD in Indonesian-Malay race. The investigators collected data about study participants' characteristics, conducted physical examination and laboratory examination, which include BsmI polymorphisms in vitamin D receptor gene.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 2 diabetes mellitus patient

• Indonesian-Malay race

• Had signed the informed consent

Exclusion Criteria:

• Urinary tract infection

• Pregnant patient

• Fever

• In menstrual period

• Had undergone hemodialysis or peritoneal dialysis

• Had used non steroid antiinflammatory drugs (NSAIDs)

• Postexercise

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Locations

Country	Name	City	State
Indonesia	dr. Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (18)

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.

Abbate M, Zoja C, Remuzzi G. How does proteinuria cause progressive renal damage? J Am Soc Nephrol. 2006 Nov;17(11):2974-84. Epub 2006 Oct 11. Review. — View Citation

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. Review. — View Citation

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. doi: 10.4103/0019-5359.53164. — View Citation

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

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. — View Citation

Giunti S, Barit D, Cooper ME. Mechanisms of diabetic nephropathy: role of hypertension. Hypertension. 2006 Oct;48(4):519-26. Epub 2006 Sep 4. Review. — View Citation

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.

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

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

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. 201 — View Citation

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

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. — View Citation

Tseng CH. Lipid abnormalities associated with urinary albumin excretion rate in Taiwanese type 2 diabetic patients. Kidney Int. 2005 Apr;67(4):1547-53. — View Citation

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. Epub 2003 — View Citation

Vedralová M, Kotrbova-Kozak A, Zelezníková V, Zoubková H, Rychlík I, Cerná 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 nephrop — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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