CClinicalTrials.gg
Status unknownNCT04962399Updated Jul 15, 2021

Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy

An observational study in Diabetic Nephropathy Type 2, sponsored by Zheng Guo. Status unknown. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-15.

Sponsored by Zheng Guo · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
180
Ages
18 Years to 65 Years
Sex
All
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Study 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.

02

Conditions studied

  • Diabetic Nephropathy Type 2
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 180 is close to the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Zheng Guo is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testEnzyme 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.

    Also known as: Real time fluorescent quantitative PCR

06

What researchers measure

Primary outcomes

  1. N/OFQ

    Serum N / OFQ levels

    Time frame: 24 hours

  2. IL-6

    Serum IL-6 levels

    Time frame: 24 hours

  3. rs1800796

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

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04962399
Lead sponsor
Zheng Guo
Responsible party
Zheng Guo (professor, Second Hospital of Shanxi Medical University) — Sponsor-investigator
First posted
Jul 15, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Jul 31, 2022 (estimated)
Completion
Oct 31, 2022 (estimated)
Last update
Jul 15, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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