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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476627
• Other study ID #: JS-2136
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: August 2022
• Source: Peking Union Medical College Hospital
• Contact: Yan Liu
• Phone: +86-15811568692
• Email: liuyanpumch[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Hypertension
• Hyperuricemia
• Kidney Diseases
• Metabolic Diseases
• Obesity
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Biomarkers
Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with End Stage Renal Disease	End Stage Renal Disease	3 years
Primary	Number of Participants with Adverse cardiovascular events	Adverse cardiovascular events	3 years
Primary	Number of Participants with all cause death	All cause death	3 years
Secondary	Number of Participants with eGFR decline	the decline of eGFR during follow-up	3 years
Secondary	Number of Participants with Complications of CKD	The complications of CKD	3 years
Secondary	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
Secondary	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