- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06123871
Expression Analysis of Urinary Exosome in Type 2 Diabetic Kidney Disease and Evaluation of Its Clinical Diagnostic Value
November 3, 2023 updated by: Yipeng Liu
Expression Analysis of Urinary Exosome miR-136-5p in Type 2 Diabetic Nephropathy and Evaluation of Its Clinical Diagnostic Value
Expression analysis of urinary exosome miR-136-5p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
- Preliminary screening of miRNAs: Through GEO database and reading related literature, miRNAs differentially expressed in type 2 diabetes and diabetic nephropathy were selected as potential candidate biomarkers for follow-up verification.
- Collection and treatment of clinical samples: 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.
- Isolation and identification of urinary exosomes: Ultrafast centrifugation method was used to separate the treated urine samples of exosomes, and then identified by transmission electron microscopy, nanoparticle analysis and Western blot respectively.
- Real-time PCR was used to detect the changes in urinary exosomal miRNA expression levels of the two groups of patients, and statistical analysis and correlation analysis of clinical indicators of the differentially expressed mirnas were performed.
- Target gene prediction and enrichment pathway analysis of differentially expressed mirnas were performed to screen out pathways that might be related to the occurrence and development of DKD, and then the relevant pathways were verified by immunofluorescence, immunocoprecipitate, Western blot, Real- time PCR and other methods.
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
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Jinan, Shandong, China, 250000
- Qianfoshan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
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.
Description
Inclusion Criteria:
- 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≥300mg/g.
Exclusion Criteria:
- Refused to enroll patients;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 2 diabetes group
The group was based on the clinically confirmed diagnosis of type 2 diabetes
|
The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken
|
Diabetic nephropathy group
The group was based on the clinically confirmed diagnosis of type 2 diabetes.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.
|
The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preliminary screening of miRNA
Time Frame: 2020-2024
|
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
Time Frame: 2020-2024
|
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
|
Statistical analysis and target gene prediction of misexpressed mirnas and enrichment pathway analysis
Time Frame: 2020-2024
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Estimated)
December 30, 2023
Study Completion (Estimated)
January 31, 2024
Study Registration Dates
First Submitted
November 3, 2023
First Submitted That Met QC Criteria
November 3, 2023
First Posted (Estimated)
November 9, 2023
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 3, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YXLL-KY-2023(127)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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