Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension; Obesity; Diabetes Mellitus; Chronic Kidney Diseases; Hyperuricemia
• Intervention / Treatment: Diagnostic test: Biomarkers

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Yan Liu; Phone Number: +86-15811568692; Email: liuyanpumch@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Yan Liu; Phone Number: +86-15811568692; Email: liuyanpumch@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is consecutively enrolled from outpatient and inpatient department of our hospital.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Pregnant or lactation patients;
• Patients with unstable vital signs, failure of other organs or dysphoria.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertension Group	Diagnostic test: Biomarkers; Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.
Diabetes Group	Diagnostic test: Biomarkers; Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.
Hyperuricemia	Diagnostic test: Biomarkers; Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.
Obesity	Diagnostic test: Biomarkers; Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with End Stage Renal Disease	End Stage Renal Disease	3 years
Number of Participants with Adverse cardiovascular events	Adverse cardiovascular events	3 years
Number of Participants with all cause death	All cause death	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with eGFR decline	the decline of eGFR during follow-up	3 years
Number of Participants with Complications of CKD	The complications of CKD	3 years
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.	3 years
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.	3 years

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Limeng Chen, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: biomarker; chronic kidney disease; metabolic diseases; functional imaging techniques
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia; Metabolic Diseases
• Other Study ID Numbers: JS-2136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: De-privatized data are to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No