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

NCT ID: NCT01845870

Last Updated: 2013-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus With Diabetic Nephropathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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urinary albumin >300mg/24h

none extra intervention was given by the investigator

No interventions assigned to this group

urinary albumin <30mg/24h

none extra intervention was given by the investigator

No interventions assigned to this group

urinary albumin 30 to 300mg/24h

none extra intervention was given by the investigator

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fei Guo

chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chenlin Dai, MD

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Locations

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General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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TIJMUGHE

Identifier Type: -

Identifier Source: org_study_id

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