Clinical trial NCT03621384: Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease
Official title: Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Kidney Disease
Keywords: BsmI
Diabetic kidney disease
Polymorphisms
Vitamin D receptor gene
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Association between BsmI Polymorphisms in Vitamin D Receptor Gene and Diabetic Kidney Disease
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Pringgodigdo Nugroho, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Suhardjono, Prof., MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Aida Lydia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Kuntjoro Harimurti, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indonesia University
name: Dekta Filantropi Esa, MD
role: PRINCIPAL_INVESTIGATOR
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