Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Nephropathy Type 2
• Intervention / Treatment: Diagnostic test: Enzyme linked immunosorbent assay

• Study Type: Observational
• Enrollment (Anticipated): 180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the second hospital of Shanxi Medical University from May 2021 to October 2022

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DKD group; 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; Serum N / OFQ and IL-6 levels were detected，and the genotype and allele frequencies of rs1800796 in IL-6 gene were determined.; Other Names: Real time fluorescent quantitative PCR
TDM group; Type 2 diabetes mellitus without diabetic nephropathy	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.; Other Names: Real time fluorescent quantitative PCR
control group; Health examination population in the same period	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.; Other Names: Real time fluorescent quantitative PCR

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zheng Guo

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: hanyi20210703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No