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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fei Guo, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier:
NCT01845870
First received: April 26, 2013
Last updated: June 5, 2013
Last verified: April 2013

April 26, 2013
June 5, 2013
February 2012
April 2013   (final data collection date for primary outcome measure)
determination of urinary albumin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Urinary albumin of 24h were measured by Scientific Management of HITACHI 7600-020 Biochemical Analyzer.
determination of urinary albumin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01845870 on ClinicalTrials.gov Archive Site
determination of serum vitamin D metabolites [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Serum vitamin D metabolites were detected by VITROS ECI systerm through a ELISA methods.
determination of serum vitamin D metabolites [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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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

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.

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Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Blood samples were collected after an overnight fast to evaluate glycosylated hemoglobin A1c(HbA1c), hemoglobin (Hb), serum albumin (ALB), serum creatinine (SCR), serum urea nitrogen (BUN), uric acid (UA), serum calcium (Ca), serum phosphate (P), serum alanine transferase (ALT), serum aspartate aminotransferase (AST), serum alkaline phosphatase (ALP), serum 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D. Urine albumin, calcium and phosphate of 24 hour were also evaluated.

Non-Probability Sample

Patients with T2DM were recruited from the general hospital of Tianjin Medical University in China .

Type 2 Diabetes Mellitus With Diabetic Nephropathy
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  • urinary albumin >300mg/24h
    none extra intervention was given by the investigator
  • urinary albumin <30mg/24h
    none extra intervention was given by the investigator
  • urinary albumin 30 to 300mg/24h
    none extra intervention was given by the investigator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01845870
TIJMUGHE
No
Fei Guo, Tianjin Medical University General Hospital
Tianjin Medical University General Hospital
Not Provided
Study Director: Chenlin Dai, MD Tianjin Medical University General Hospital
Tianjin Medical University General Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP