Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

NCT04962399 | Unknown

• 1 other identifier: hanyi20210703
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Nephropathy Type 2

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

TDM group

Type 2 diabetes mellitus without diabetic nephropathy

Diagnostic Test: Enzyme linked immunosorbent assay

control group

Health examination population in the same period

Diagnostic Test: Enzyme linked immunosorbent assay

Interventions

Enzyme linked immunosorbent assay DIAGNOSTIC_TEST

Serum N / OFQ and IL-6 levels were detected，and the genotype and allele frequencies of rs1800796 in IL-6 gene were determined.

Also known as: Real time fluorescent quantitative PCR

DKD group; TDM group; control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zheng Guo: lead

Study Design

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

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 15, 2021
• Study Start: August 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: October 31, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-07