Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
With the development of China's economy, people's living standard have improved, and the dietary structure have changed. Metabolic diseases, such as hypertension, diabetes, hyperuricemia and obesity have gradually become an important health burden in China. The pathophysiological mechanism of renal injury caused by metabolic diseases has always been a hotspot of research. Currently, it is believed that various mechanisms including the activation of Renin-Angiotensin-Aldosterone System, vascular endothelial dysfunction, oxidative stress and inflammatory process may be involved. Although there are differences in renal pathological manifestations caused by different metabolic diseases, the kidney will eventually present ischemic changes and fibrosis with the progression of the disease. So there must be some common pathogenesis. This study is designed to build a disease cohort of patients with chronic kidney disease caused by metabolic diseases, to identify risk factors leading to disease progression and to explore biomarkers for early diagnosis and treatment of kidney damage.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The diagnosis of metabolic diseases were confirmed;
Be able to understand the process of the research;
Volunteer for participation and be able to sign the informed consent.
Disqualifiers
Age <18 yrs or >80yrs;
Patients with primary and secondary glomerular diseases
Patients with other comorbidities that could affect the volume or the components of the kidney, such as renal cysts, polycystic kidney disease, medullary sponge kidney, hydronephrosis, renal artery stenosis, renal vein thrombosis and/or renal tumors;
Contraindications for MRI examination;
Trial population
The study population is consecutively enrolled from outpatient and inpatient department of our hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biomarkers
Diagnostic testBlood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Hypertension Group1 intervention
Group B: Diabetes Group1 intervention
Group C: Hyperuricemia1 intervention
Group D: Obesity1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with End Stage Renal Disease
End Stage Renal Disease
Time frame
3 years2
Number of Participants with Adverse cardiovascular events
Adverse cardiovascular events
Time frame
3 years3
Number of Participants with all cause death
All cause death
Time frame
3 yearsSecondary outcomes
1
Number of Participants with eGFR decline
the decline of eGFR during follow-up
Time frame
3 years2
Number of Participants with Complications of CKD
The complications of CKD
Time frame
3 years3
Life quality assessment with short form-36 (SF-36)
The SF-36 is a patient-reported instrument designed to assess overall health status; it is usually utilized to measure patients' quality of life and used primarily in research. Increasing SF-36 scores are indicative of improving health status.
Time frame
3 years4
Advanced Intelligence Assessment with Mini-Mental State Examination (MMSE)
The MMSE is scored on a 30-point scale, with items that assess orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point) . While different cutoff points have been used across studies, scores ≤23 are most commonly regarded as abnormal and indicative of cognitive impairment.
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov