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

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ClinicalTrials.gov Identifier: NCT01845870
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : June 6, 2013
Information provided by (Responsible Party):
Fei Guo, Tianjin Medical University General Hospital

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.

Condition or disease
Type 2 Diabetes Mellitus With Diabetic Nephropathy

Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Study Whether Serum 1,25-dihydroxyvitamin D Levels Could be an Indicator for Dysfunction of Renal Tubules
Study Start Date : February 2012
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. determination of urinary albumin [ Time Frame: 8 weeks ]
    Urinary albumin of 24h were measured by Scientific Management of HITACHI 7600-020 Biochemical Analyzer.

Secondary Outcome Measures :
  1. determination of serum vitamin D metabolites [ Time Frame: 8 weeks ]
    Serum vitamin D metabolites were detected by VITROS ECI systerm through a ELISA methods.

Biospecimen Description:
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.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with T2DM were recruited from the general hospital of Tianjin Medical University in China .

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01845870

China, Tianjin
General Hospital of Tianjin Medical University
Tianjin, Tianjin, China, 300052
Sponsors and Collaborators
Tianjin Medical University General Hospital
Study Director: Chenlin Dai, MD Tianjin Medical University General Hospital

Responsible Party: Fei Guo, chief physician, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT01845870     History of Changes
Other Study ID Numbers: TIJMUGHE
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents