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
  Purpose

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
Type 2 Diabetes Mellitus With Diabetic Nephropathy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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.


Enrollment: 162
Study Start Date: February 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 .

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01845870

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

No publications provided

Responsible Party: Fei Guo, chief physician, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT01845870     History of Changes
Other Study ID Numbers: TIJMUGHE
Study First Received: April 26, 2013
Last Updated: June 5, 2013
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on July 23, 2014