The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy

NCT02204280 | Completed DMC

• 1 other identifier: HebeiMUTH
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less value as a marker in DM because it has a variety of causes, including hypertension. Thus, additional markers are needed to identify patient groups with a high risk of developing overt diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to identify its significance in the diagnosis of diabetic nephropathy.

Conditions

Diabetic Nephropathy

Keywords

UbA52;diabetic nephropathy ;diabetic;ELISA

Outcome Measures

Primary Outcomes (1)

• The urine UbA52 levels in 30 patients with type 2 diabetic mellitus,30 patients with diabetic nephropathy，30 patients with proteinuria due to nondiabetic renal disease and 30 healthy persons

  12 months

Study Arms (4)

Type 2 Diabetic

Patiens with type 2 diabetic which conform to the WHO in 1999 diabetes diagnostic criteria.

Diabetic With macro-or Microalbuminuria

Patients with diabetic with macro-or microalbuminuria.

proteinuria,nondiabetic renal disease

Patients with proteinuria due to nondiabetic renal disease,such as IgA nephropathy,FSGS,Hypertensive renal damage and MN.

healthy controls

Healthy person.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with type 2 diabetic,diabetic with macro-or microalbuminuria and proteinuria due to nondiabetic renal disease from Hebei Medical University the Third Hospital.

You may qualify if:

• diabetes diagnostic criteria (WHO, 1999),age \< 80 years old, gender not limited;
• diabetic with macro-or microalbuminuria;
• the subjects not took hemodialysis;
• with proteinuria due to nondiabetic renal disease :Hypertensive renal damage,drug-induced acute interstitial nephritis, IgA, primary membranous nephropathy,FSGS or MCD, which were confirmed by renal biopsy.

You may not qualify if:

• acute diabetic complications: ketoacidosis, hypertonic coma;
• the diagnosis of malignant tumors, particularly affecting the liver and kidney function of tumor and the application of radiation and chemotherapy treatment of patients;
• cardiac insufficiency, heart function class 3 or above;
• data is not complete, have an impact on the results;
• not hospitalized patients;
• accept long-term oral or static point methods such as steroid hormone therapy, application of renal toxicity of drugs;
• with the exception of primary kidney disease and other causes lead to eye disease;
• the combination of respiratory system infection or other systemic diseases and patients with severe primary diseases, vigorous exercise within 24 hours;
• pregnancy or breastfeeding women
• there is a clear liver disease, its alanine or aspertate aminotransferase 2 times higher than normal limit;
• reluctant to collaborators and psychiatric patients;
• has been undergoing hemodialysis.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator

Related Publications (1)

• Xu X, Dong Y, Liu M, Li Y, Zhang Y. Clinical significance of UbA52 level in the urine of patients with type 2 diabetes mellitus and diabetic kidney disease. Nefrologia (Engl Ed). 2021 Sep-Oct;41(5):548-555. doi: 10.1016/j.nefroe.2021.11.009.

  PMID: 36165137 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

morning urine

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 30, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2014-07