Serum 1,25-dihydroxyvitamin D Levels in Type 2 Diabetes Mellitus Patients With Different Levels of Albuminuria

Study Whether Serum 1,25-dihydroxyvitamin D Levels Could be an Indicator for Dysfunction of Renal Tubules

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01845870

Acronym

Enrollment

162

Registered

2013-05-03

Start date

2012-02-29

Completion date

2013-04-30

Last updated

2013-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus With Diabetic Nephropathy

Brief summary

Diabetic nephropathy(DN)is a major microvascular complication of diabetes.Renal injury may be presented with the characteristics of albuminuria, and its main pathological change is glomerular sclerosis. However, both glomerular lesions such as glomerulosclerosis, glomerular basement membrane thickness and tubulointerstitial fibrosis have been found in both type 1 and type 2 diabetic patients with normal urinary albumin excretion rate, moreover the tubular injury may be the primary pathological change in diabetic renal injury not only the secondary change brought on by glomerular injury. Thus, if overt urinary albumin exists in T2DM patients, the tubular injury may be severe already. An index which is predominant, sensitive and convenient to be measured should be purposed.It is predicted that insufficient renal 1-alpha hydroxylase may play a critical role in diabetic nephropathy. Then the investigators present the presumption that the activity of renal 1-alpha hydroxylase could reflect the degrees of tubulointerstitial injury, using serum 1,25-dihydroxyvitamin D level as an index.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* age \>18 years, DM duration \>1 year, all of the patients were predialysis

Exclusion criteria

* history of liver or kidney disease, malignancy, current pregnancy, extensive dermatologic disease, evidence of metabolic bone disease and hyper-/hypo- thyroidism that would affect mineral metabolism. Patients who were taking native or active vitamin D, steroids, phosphate binders, or medications that affect vitamin D metabolism were also excluded.

Design outcomes

Primary

Measure	Time frame	Description
determination of urinary albumin	8 weeks	Urinary albumin of 24h were measured by Scientific Management of HITACHI 7600-020 Biochemical Analyzer.

Secondary

Measure	Time frame	Description
determination of serum vitamin D metabolites	8 weeks	Serum vitamin D metabolites were detected by VITROS ECI systerm through a ELISA methods.

Countries

China

Outcome results