Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

Diabetic Nephropathy Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04962399
• Other study ID #: hanyi20210703
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2021
• Source: Second Hospital of Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ? 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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy Type 2
• Kidney Diseases

Intervention

Diagnostic Test:
• Enzyme linked immunosorbent assay
Serum N / OFQ and IL-6 levels were detected,and the genotype and allele frequencies of rs1800796 in IL-6 gene were determined.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zheng Guo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N/OFQ	Serum N / OFQ levels	24 hours
Primary	IL-6	Serum IL-6 levels	24 hours
Primary	rs1800796	The rs1800796 polymorphism in the promoter region of IL-6 gene was analyzed	24 hours