Expression Analysis of Urinary Exosome in Type 2 Diabetic Nephropathy and Evaluation of Its Clinical Diagnostic Value

NCT06097351 | Unknown

• 1 other identifier: YXLL-KY-2023(106)
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Expression analysis of urinary exosome miR-142-3p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (3)

• 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

• Clinical sample collection and processing

  (2) 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≥30/g. Subsequently, the collected samples were centrifuged and retained for supernatant.

  2020-2024

• Statistical analysis and target gene prediction of misexpressed mirnas and enrichment pathway analysis

  Statistical analysis and correlation analysis of clinical indicators of differentially expressed mirnas were performed to further evaluate their clinical diagnostic value. Subsequently, the target genes of the mirnas differentially expressed in urinary exosomes of the two groups were analyzed by miRTarBase database and R software package, and the relevant pathways were screened out through KEGG enrichment pathway analysis. Subsequently, the relevant pathways were verified by immunofluorescence, immunocoprecipitation, Western blot, Real-time PCR and other methods.

  2020-2024

Study Arms (2)

Type 2 diabetes group

The group was based on the clinically confirmed diagnosis of type 2 diabetes

Other: Grouping based on previous laboratory results, no intervention.

Diabetic nephropathy group

The group was based on the clinically confirmed diagnosis of type 2 diabetes.Patients were re-screened strictly according to the following admission criteria: persistent albuminuria and/or decreased eGFR, while other causes of chronic kidney disease (CKD) were excluded. When diabetes mellitus is identified as the cause of kidney damage and other primary and secondary glomerular diseases and systemic diseases are excluded, at least one of the following conditions can be diagnosed as DKD: (1) Urinary Albumin/Creatinine Ratio (UACR)≥30 mg/g or Urinary albumin excretion rate (UAER)≥30 mg/24 h, The UACR or UAER was checked again within 3 to 6 months, and 2 out of 3 times reached or exceeded the critical value; Eliminate other interfering factors such as infection; (2) eGFR\< 60 ml·min-1· (1.73 m2) -1 for more than 3 months; (3) Renal biopsy was consistent with DKD pathological changes

Other: Grouping based on previous laboratory results, no intervention.

Interventions

Grouping based on previous laboratory results, no intervention. OTHER

The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken

Diabetic nephropathy group; Type 2 diabetes group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a clinically confirmed diagnosis of type 2 diabetes during hospitalization in the Department of nephrology and Endocrinology from December 2020 to June 2022.

You may qualify if:

• Age ≥18 years old;
• Previously diagnosed with type 2 diabetes;
• Typical diabetic symptoms (polydipsia, polydipsia, polyuria and weight loss) plus random blood glucose ≥11.1mmol/l;
• Fasting blood glucose ≥7.0mmol/l, fasting is defined as at least 8 hours without intake of calories;
• 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;
• With or without UACR≥30mg/g.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Yipeng Liu: lead

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Yipeng Liu

  Qianfoshan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 24, 2023
• Study Start: June 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: January 31, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)