Diabetic Kidney DiseaseNCT03621384
Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease
An observational study of Diabetic Kidney Disease, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- How many people
- 93 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Type 2 diabetes mellitus patient
- Indonesian-Malay race
- Had signed the informed consent
Who cannot join
- Urinary tract infection
- Pregnant patient
- Fever
- In menstrual period
- Had undergone hemodialysis or peritoneal dialysis
- Had used non steroid antiinflammatory drugs (NSAIDs)
- Postexercise
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
dr. Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
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)
Read the 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.
- Conditions
- Diabetic Kidney Disease
- Keywords
- BsmI, Diabetic kidney disease, Polymorphisms, Vitamin D receptor gene
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pringgodigdo Nugroho, MD, Universitas Indonesia
- Investigators
- Pringgodigdo Nugroho, MD, Principal investigator, Universitas IndonesiaSuhardjono, Prof., MD, PhD, Principal investigator, Universitas IndonesiaAida Lydia, MD, PhD, Principal investigator, Universitas IndonesiaKuntjoro Harimurti, MD, PhD, Principal investigator, Universitas IndonesiaDekta Filantropi Esa, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621384
- Sponsor's protocol ID
- 756/UN2.F1/ETIK/2014
- Status last verified
- Aug 2018
- First submitted
- 22 May 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22737281Zhao 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.
PubMed 14768849Tseng 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.
PubMed 15780110Vedovato 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.
PubMed 14704836Dullaart 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.
PubMed 8432221Abbasi MA, Abro A, Sheikh M. Smoking is related to albumin excretion in type 2 diabetes mellitus. Pak J Physiol. 2006;2(2):45-8.
Koroshi A, Idrizi A. Renoprotective effects of Vitamin D and renin-angiotensin system. Hippokratia. 2011 Oct;15(4):308-11.
PubMed 24391410Bid 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.
PubMed 19584489Zhang 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.
PubMed 22245613Vedralova 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.
PubMed 22777106Dewi K. Penurunan fungsi ginjal pada pasien DM tipe 2 di Poliklinik Endokrin Metabolik RSUPN Cipto Mangunkusumo. University of Indonesia; 2007.
Indra T. Asosiasi antara status vitamin D (25(OH)D) dengan albuminuria pada pasien diabetes melitus tipe 2. University of Indonesia; 2013.
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.
PubMed 16952978Bayliss 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.
PubMed 22638939
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of BsmI Polymorphisms in Vitamin D Receptor Gene With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT03621384
- Acronym / sponsor ID
- 756/UN2.F1/ETIK/2014
- Conditions
- Diabetic Kidney Disease
- Keywords
- BsmI, Diabetic kidney disease, Polymorphisms, Vitamin D receptor gene
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus patient
- Indonesian-Malay race
- Had signed the informed consent
Key exclusion criteria (7 listed)
- Urinary tract infection
- Pregnant patient
- Fever
- In menstrual period
- Had undergone hemodialysis or peritoneal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association between BsmI Polymorphisms in Vitamin D Receptor Gene and Diabetic Kidney Disease
Time frame: 1 month
This study investigated association between BsmI polymorphisms in vitamin D receptor gene with diabetic kidney disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Results publicationPerhimpunan Nefrologi Indonesia. Report of Indonesian Renal Registry. Jakarta; 2011.
- Results publication: PubMed 22737281Ramachandran 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.
- Results publication: PubMed 14768849Zhao 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.
- Results publication: PubMed 15780110Tseng 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.
- Results publication: PubMed 14704836Vedovato 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.
- Results publication: PubMed 8432221Dullaart 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.
- Results publicationAbbasi MA, Abro A, Sheikh M. Smoking is related to albumin excretion in type 2 diabetes mellitus. Pak J Physiol. 2006;2(2):45-8.
- Results publication: PubMed 24391410Koroshi A, Idrizi A. Renoprotective effects of Vitamin D and renin-angiotensin system. Hippokratia. 2011 Oct;15(4):308-11.
- Results publication: PubMed 19584489Bid 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.
- Results publication: PubMed 22245613Zhang 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.
- Results publication: PubMed 22777106Vedralova 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.
- Results publicationDewi K. Penurunan fungsi ginjal pada pasien DM tipe 2 di Poliklinik Endokrin Metabolik RSUPN Cipto Mangunkusumo. University of Indonesia; 2007.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pringgodigdo Nugroho, MD principal investigator
Universitas Indonesia
Suhardjono, Prof., MD, PhD principal investigator
Universitas Indonesia
Aida Lydia, MD, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between BsmI Polymorphisms in Vitamin D Receptor Gene and Diabetic Kidney Disease (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621384, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.