Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

• Conditions: Diabetic Nephropathy Type 2
• Interventions: Diagnostic Test: Enzyme linked immunosorbent assay

• Registration Number: NCT04962399
• Lead Sponsor: Zheng Guo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-04
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15
• Study Start: 2021-08-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DKD group	Enzyme linked immunosorbent assay	Patients with type 2 diabetes mellitus complicated with diabetic nephropathy diagnosed by the second hospital of Shanxi Medical University
TDM group	Enzyme linked immunosorbent assay	Type 2 diabetes mellitus without diabetic nephropathy
control group	Enzyme linked immunosorbent assay	Health examination population in the same period

Primary Outcome Measures

Name	Time	Method
N/OFQ	24 hours	Serum N / OFQ levels
IL-6	24 hours	Serum IL-6 levels
rs1800796	24 hours	The rs1800796 polymorphism in the promoter region of IL-6 gene was analyzed