Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

Study Overview
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Brief Summary
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At present, the early diagnosis ability of diabetic nephropathy (DKD) is relatively poor, leading to some missed diagnosis of early disease patients. At the same time, because DKD patients have complex metabolic disorders, once they develop to end-stage renal disease, compared with other renal diseases, the treatment of DKD is more difficult and the prognosis is poor. At present, the main treatment for DKD is to strengthen blood glucose control and control blood pressure through renin angiotensin aldosterone system (RAAS) to delay the occurrence and development of DKD, but it can not reduce the risk of most patients progressing to end-stage renal disease (ESRD). In recent years, it is becoming a new therapeutic target for DKD to control the inflammatory response by targeting the inflammatory factors and inflammatory signaling pathways. Therefore, this study attempts to explore the correlation between N / OFQ and the occurrence and development of type 2 DKD, and seek new theoretical basis for the potential treatment of inflammation.

Official Title
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Association of Serum N/OFQ, IL-6 and IL-6 Gene Polymorphisms With Type 2 Diabetic Nephropathy

Conditions
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Diabetic Nephropathy Type 2

Intervention / Treatment
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* Diagnostic Test: Enzyme linked immunosorbent assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes patients are in line with the relevant diagnostic criteria in China's guideline for prevention and treatment of type 2 diabetes (2017 Edition). patients with diabetic nephropathy are in line with the relevant diagnostic criteria in the expert consensus on diabetic nephropathy (2014 Edition). Exclusion Criteria: Primary kidney disease (e.g. acute and chronic glomerulonephritis, immune and hereditary nephropathy, pyelonephritis, gout related nephropathy, etc.) Abnormal changes of microalbuminuria and urine glucose caused by other factors (such as urinary system infection, fever, 24-hour strenuous exercise, intractable hypertension, congestive heart failure, pregnancy, ketoacidosis, etc.) Failure of other important organs (heart, lung and liver) in the whole body; Activity of urinary sediment; The glomerular filtration rate decreased by more than 30% within 2-3 months after treatment with angiotensin converting enzyme inhibitor (ACEI) or angiotensin Ⅱ receptor antagonist (ARB); Patients with cancer, trauma, stress and other endocrine diseases; Patients with type 1 diabetes and kidney injury; Congenital mental retardation or poor compliance; The informed consent was not signed.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DKD group<br>Patients with type 2 diabetes mellitus complicated with diabetic nephropathy diagnosed by the second hospital of Shanxi Medical University | Diagnostic Test: Enzyme linked immunosorbent assay<br>* Serum N / OFQ and IL-6 levels were detected，and the genotype and allele frequencies of rs1800796 in IL-6 gene were determined.<br>* Other names: Real time fluorescent quantitative PCR;|
| TDM group<br>Type 2 diabetes mellitus without diabetic nephropathy | Diagnostic Test: Enzyme linked immunosorbent assay<br>* Serum N / OFQ and IL-6 levels were detected，and the genotype and allele frequencies of rs1800796 in IL-6 gene were determined.<br>* Other names: Real time fluorescent quantitative PCR;|
| control group<br>Health examination population in the same period | Diagnostic Test: Enzyme linked immunosorbent assay<br>* Serum N / OFQ and IL-6 levels were detected，and the genotype and allele frequencies of rs1800796 in IL-6 gene were determined.<br>* Other names: Real time fluorescent quantitative PCR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N/OFQ | Serum N / OFQ levels | 24 hours | 
| IL-6 | Serum IL-6 levels | 24 hours | 
| rs1800796 | The rs1800796 polymorphism in the promoter region of IL-6 gene was analyzed | 24 hours |