Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

Sponsor
Zheng Guo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04962399
Collaborator
(none)
180
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Enzyme linked immunosorbent assay

Study Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Association of Serum N/OFQ, IL-6 and IL-6 Gene Polymorphisms With Type 2 Diabetic Nephropathy
Anticipated Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. N/OFQ [24 hours]

      Serum N / OFQ levels

    2. IL-6 [24 hours]

      Serum IL-6 levels

    3. rs1800796 [24 hours]

      The rs1800796 polymorphism in the promoter region of IL-6 gene was analyzed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zheng Guo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zheng Guo, professor, Second Hospital of Shanxi Medical University
    ClinicalTrials.gov Identifier:
    NCT04962399
    Other Study ID Numbers:
    • hanyi20210703
    First Posted:
    Jul 15, 2021
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 15, 2021