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Completed

NCT Number: NCT01845870

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus With Diabetic Nephropathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, 300052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

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

Acronym: DM

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 3, 2013
Registry last updated
Jun 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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