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

Type 2 Diabetes Mellitus With Diabetic Nephropathy Clinical Trial

— DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845870
• Other study ID #: TIJMUGHE
• Status: Completed
• Phase: N/A
• First received: April 26, 2013
• Last updated: June 5, 2013
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Type 2 Diabetes Mellitus With Diabetic Nephropathy

Locations

Country	Name	City	State
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of urinary albumin	Urinary albumin of 24h were measured by Scientific Management of HITACHI 7600-020 Biochemical Analyzer.	8 weeks	No
Secondary	determination of serum vitamin D metabolites	Serum vitamin D metabolites were detected by VITROS ECI systerm through a ELISA methods.	8 weeks	No