Diabetic Nephropathy Type 2NCT04931537
Screening and Application Research of Early Diabetic Nephropathy Markers Based on Lipidomics.
An observational study of Diabetic Nephropathy Type 2 and Biomarker, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Diabetic nephropathy (DN) is one of the major microvascular complications associated with diabetic patients, and also the major global cause of chronic kidney disease and end-stage renal disease (ESRD). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy Type 2, Biomarker
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were 20-80 years old and of either gender
Who may be able to join
- Subjects who have signed informed consent.
- Subjects were 20-80 years old and of either gender.
- Subjects showed good compliance, and the follow-up data was available for >5 years.
Who cannot join
- Meet the 1999 World Health Organization (WHO) diagnostic criteria for T1DM、T2DM;
- Renal diseases caused by other causes, including primary and secondary;
- All kinds of acute infections;
- The expected life expectancy (life expectancy or related diseases) was less than 5 years according to the researcher's judgment.
- Drug users or drug abusers;
- Sexually transmitted diseases such as viral hepatitis, AIDS and syphilis, and infectious diseases such as tuberculosis are in an active period;
- Any situation judged by the researcher that affects enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital Zhejiang University Schoolof Medicine
Hangzhou, 310009
Chao Zheng, MD. PhD, 8615057585907, wallbb_1022@163.com
Yikai Zhang, PhD
About this study
Diabetic nephropathy (DN) is one of the major microvascular complications associated with diabetic patients, and also the major global cause of chronic kidney disease and end-stage renal disease (ESRD). Albuminuria and estimated glomerular filtration rate (eGFR) are currently recognized clinical indicators for early diagnosis of DN, however, the sensitivity and specificity are unsatisfactory. The early identification and treatment of DKD are conducive to lowering the risk of kidney damage by as much as 50%. Therefore, it is particularly critical to find new biomarkers to reflect the potential DKD lesions in the clinical silent period earlier and more accurately. Therefore, this study intends to analyze the differentially expressed lipids in early DKD, T2DM and healthy adults by mass spectrometry, and verify the related results by larger samples, so as to screen out early markers of DKD and achieve the ultimate goal of clinical application.
Read the detailed description
The present study was a scientific research project concurrently conducted by clinical and laboratory. In term of clinical research, the basic personal data, medical history, physical examination and auxiliary examination results of subjects were mainly recorded. Whereas in term of basic research, the serum, plasma and urine samples of patients were collected for serological and metabonomics research to find new biomarkers.
First, we recruited the patients who met the inclusion criteria. The patients' serum, plasma and urine were collected at baseline after obtaining informed patient consent. Simultaneously, the basic information, anthropometric indicators (including height, weight, waist circumference, hip circumference, blood pressure), past history, family history, menstrual history, birth history, medication history, lifestyle of the patients were registered, and the corresponding laboratory examination and auxiliary examination were carried out according to the diagnostic process. All data and data were entered into the database for later analysis. After the initial diagnosis, the patients were enrolled in the current trial. The patients were followed up annually until the last follow-up visit, and the complete follow-up was conducted for at least 5 years. Each follow-up followed the principles of routine clinical diagnosis and treatment. In addition, the patients' serum, plasma and urine samples were collected once a year during follow-up, and a centralized test of glycosylated hemoglobin was performed once a year.
In this study, the pathogenesis of type 2 diabetic nephropathy was explored through multi-center standardized clinical follow-up; The potential mechanism and possible biomarkers in patients with early renal diseases of type 2 diabetes was explored through prospective long-term follow-up, so as to find novel therapeutic approaches and suitable population.
- Conditions
- Diabetic Nephropathy Type 2, Biomarker
- Keywords
- Diabetic Nephropathy Type 2, Metabonomics
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Albumin Creatinine Ratio，UACR
Urinary Albumin Creatinine Ratio
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 May 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Nephropathy Type 2Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University, Lishui Country People's Hospital
- Responsible party
- Sponsor
- Investigators
- Chao Zheng, MD,PhD, Principal investigator, the Second Affiliated Hospital Zhejiang University Schoolof MedicineYikai Zhang, PhD, Study director, the Second Affiliated Hospital Zhejiang University Schoolof Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931537
- Sponsor's protocol ID
- zhengchao-2
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Application Research of Early Diabetic Nephropathy Markers Based on Lipidomics.
- ClinicalTrials.gov ID
- NCT04931537
- Acronym / sponsor ID
- zhengchao-2
- Conditions
- Diabetic Nephropathy Type 2, Biomarker
- Keywords
- Diabetic Nephropathy Type 2, Metabonomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Wenzhou Medical University, Lishui Country People's Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Jun 2021 (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.
Diabetic nephropathy (DN) is one of the major microvascular complications associated with diabetic patients, and also the major global cause of chronic kidney disease and end-stage renal disease (ESRD). Albuminuria and estimated glomerular filtration rate (eGFR) are currently recognized clinical indicators for early diagnosis of DN, however, the sensitivity and specificity are unsatisfactory. The early identification and treatment of DKD are conducive to lowering the risk of kidney damage by as much as 50%. Therefore, it is particularly critical to find new biomarkers to reflect the potential DKD lesions in the clinical silent period earlier and more accurately. Therefore, this study intends to analyze the differentially expressed lipids in early DKD, T2DM and healthy adults by mass spectrometry, and verify the related results by larger samples, so as to screen out early markers of DKD and achieve the ultimate goal of clinical application.
Detailed description
The present study was a scientific research project concurrently conducted by clinical and laboratory. In term of clinical research, the basic personal data, medical history, physical examination and auxiliary examination results of subjects were mainly recorded. Whereas in term of basic research, the serum, plasma and urine samples of patients were collected for serological and metabonomics research to find new biomarkers.
First, we recruited the patients who met the inclusion criteria. The patients' serum, plasma and urine were collected at baseline after obtaining informed patient consent. Simultaneously, the basic information, anthropometric indicators (including height, weight, waist circumference, hip circumference, blood pressure), past history, family history, menstrual history, birth history, medication history, lifestyle of the patients were registered, and the corresponding laboratory examination and auxiliary examination were carried out according to the diagnostic process. All data and data were entered into the database for later analysis. After the initial diagnosis, the patients were enrolled in the current trial. The patients were followed up annually until the last follow-up visit, and the complete follow-up was conducted for at least 5 years. Each follow-up followed the principles of routine clinical diagnosis and treatment. In addition, the patients' serum, plasma and urine samples were collected once a year during follow-up, and a centralized test of glycosylated hemoglobin was performed once a year.
In this study, the pathogenesis of type 2 diabetic nephropathy was explored through multi-center standardized clinical follow-up; The potential mechanism and possible biomarkers in patients with early renal diseases of type 2 diabetes was explored through prospective long-term follow-up, so as to find novel therapeutic approaches and suitable population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were 20-80 years old and of either gender
Key inclusion criteria (3 listed)
- Subjects who have signed informed consent.
- Subjects were 20-80 years old and of either gender.
- Subjects showed good compliance, and the follow-up data was available for >5 years.
Key exclusion criteria (7 listed)
- Meet the 1999 World Health Organization (WHO) diagnostic criteria for T1DM、T2DM;
- Renal diseases caused by other causes, including primary and secondary;
- All kinds of acute infections;
- The expected life expectancy (life expectancy or related diseases) was less than 5 years according to the researcher's judgment.
- Drug users or drug abusers;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary Albumin Creatinine Ratio，UACR
Time frame: 5years
Urinary Albumin Creatinine Ratio
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Diabetic Nephropathy Type 2
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
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.
Chao Zheng, MD,PhD principal investigator
the Second Affiliated Hospital Zhejiang University Schoolof Medicine
Yikai Zhang, PhD study director
the Second Affiliated Hospital Zhejiang University Schoolof Medicine
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 Type 2 and Biomarker, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 20 Jul 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Chao, MD, PhD (8615057585907, wallbb_1022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Albumin Creatinine Ratio，UACR (time frame: 5years). 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 20 Jul 2021.