Diabetic Nephropathy Clinical Trial
Official title:
Expression Analysis of Urinary Exosome miR-136-5p in Type 2 Diabetic Nephropathy and Evaluation of Its Clinical Diagnostic Value
Verified date | November 2023 |
Source | Qianfoshan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Expression analysis of urinary exosome miR-136-5p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | January 31, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Age =18 years old; 2. Previously diagnosed with type 2 diabetes; 3. Typical diabetic symptoms (polydipsia, polydipsia, polyuria and weight loss) plus random blood glucose =11.1mmol/l; 4. Fasting blood glucose =7.0mmol/l, fasting is defined as at least 8 hours without intake of calories; 5. Oral glucose tolerance test (OGTT) 2-hour blood glucose =11.1mmol/ l, using a glucose load equivalent to 75 grams of anhydrous glucose dissolved in water (venous blood was drawn in all patients; 6. With or without UACR=300mg/g. Exclusion Criteria: 1. Refused to enroll patients; 2. Type 1 diabetic nephropathy and other special types of diabetic nephropathy; 3.Patients with kidney stones and urinary system infection; 4.Patients with autoimmune system diseases, malignant tumors, and blood system diseases; 5.Patients with severe chronic cardiopulmonary disease, chronic liver and kidney disease; 6.Patients with severe infectious diseases; #7#Use of glucocorticoids, immunosuppressants or cytotoxic drugs. |
Country | Name | City | State |
---|---|---|---|
China | Qianfoshan Hospital | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Yipeng Liu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preliminary screening of miRNA | Through GEO database and reading related literature, mirnas that are differentially expressed in type 2 diabetes and diabetic nephropathy were selected as potential candidate biomarkers for follow-up verification. | 2020-2024 | |
Primary | Clinical sample collection and processing | The urine of diabetic patients was collected from the First Affiliated Hospital of Shandong First Medical University in strict accordance with the drainage standard, and the basic information of patients was registered. Meanwhile, the collected samples were divided into type 2 diabetes group and diabetic nephropathy group according to whether the urine was accompanied by UACR=300/g. Subsequently, the collected samples were centrifuged and retained for supernatant. | 2020-2024 | |
Primary | Statistical analysis and target gene prediction of misexpressed mirnas and enrichment pathway analysis | Statistical analysis and correlation analysis of clinical indicators of differenti ally expressed mirnas were performed to further evaluate their clinical diagnostic value.Subsequently, the target gen es of the mirnas differentially expressed in urinary exosomes of the two groups were analyzed by miRTarBase datab base and R software package, and the relevant pathways were screened out through KEGG enrichment pathway a analysis. Subsequently, the relevant pathways were verified by immunofluorescence, immunocoprecipitation, We estern blot, Real-time PCR and other methods. | 2020-2024 |
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