Clinical trial NCT04962399: Relationship Between Serum N/OFQ and Type 2 Diabetic Nephropathy
Official title: Association of Serum N/OFQ, IL-6 and IL-6 Gene Polymorphisms With Type 2 Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Nephropathy Type 2
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the second hospital of Shanxi Medical University from May 2021 to October 2022

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.


Eligibility criteria: 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.

Primary outcomes:
measure: N/OFQ
timeFrame: 24 hours
measure: IL-6
timeFrame: 24 hours
measure: rs1800796
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: