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

NCT01845870 | Completed

• 1 other identifier: TIJMUGHE
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus With Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

• determination of urinary albumin

  Urinary albumin of 24h were measured by Scientific Management of HITACHI 7600-020 Biochemical Analyzer.

  8 weeks

Secondary Outcomes (1)

• determination of serum vitamin D metabolites

  8 weeks

Study Arms (3)

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 Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300052, China

Location

Biospecimen

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.

Study Officials

• Chenlin Dai, MD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 3, 2013
• Study Start: February 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 6, 2013

Record last verified: 2013-04

Locations

CN (1)