Diabetic NephropathyNCT06123871
Expression Analysis of Urinary Exosome in Type 2 Diabetic Kidney Disease and Evaluation of Its Clinical Diagnostic Value
An observational study of Diabetic Nephropathy, run by Yipeng Liu at 1 site in China.
Trial summary
Expression analysis of urinary exosome miR-136-5p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Nephropathy
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Diabetic Nephropathy
- Being tested
- Grouping based on previous laboratory results, no intervention.
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes group | The group was based on the clinically confirmed diagnosis of type 2 diabetes Receives: 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.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. Receives: Other: Grouping based on previous laboratory results, no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2020-2024
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.
Measured: 2020-2024
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.
Measured: 2020-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Jun 2020
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yipeng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yipeng Liu, Qianfoshan Hospital
- Investigators
- Yipeng Liu, Study chair, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123871
- Sponsor's protocol ID
- YXLL-KY-2023(127)
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression Analysis of Urinary Exosome miR-136-5p in Type 2 Diabetic Nephropathy and Evaluation of Its Clinical Diagnostic Value
- ClinicalTrials.gov ID
- NCT06123871
- Acronym / sponsor ID
- YXLL-KY-2023(127)
- Conditions
- Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yipeng LiuUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Expression analysis of urinary exosome miR-136-5p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes group | – | Other: Grouping based on previous laboratory results, no intervention.The group was based on the clinically confirmed diagnosis of type 2 diabetes |
| Diabetic nephropathy group | – | Other: Grouping based on previous laboratory results, no intervention.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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grouping based on previous laboratory results, no intervention.The patients were grouped according to the results of previous inpatient tests, and no intervention measures were taken | Other | Diabetic nephropathy group, Type 2 diabetes group |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yipeng Liu study chair
Qianfoshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy, run by Yipeng Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary screening of miRNA (time frame: 2020-2024). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.