NCT05476627

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2022Jul 2027

Study Start

First participant enrolled

July 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

July 25, 2022

Last Update Submit

August 12, 2022

Conditions

Keywords

chronic kidney diseasemetabolic diseasesbiomarkerfunctional imaging techniques

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Number of Participants with eGFR decline

    3 years

  • Number of Participants with Complications of CKD

    3 years

  • Life quality assessment with short form-36 (SF-36)

    3 years

  • Advanced Intelligence Assessment with Mini-Mental State Examination (MMSE)

    3 years

Study Arms (4)

Hypertension Group

Diagnostic Test: Biomarkers

Diabetes Group

Diagnostic Test: Biomarkers

Hyperuricemia

Diagnostic Test: Biomarkers

Obesity

Diagnostic Test: Biomarkers

Interventions

BiomarkersDIAGNOSTIC_TEST

Blood,urine and imaging biomarkers for early diagnosis and prediction of prognosis.

Diabetes GroupHypertension GroupHyperuricemiaObesity

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertensionDiabetes MellitusHyperuricemiaObesityMetabolic Diseases

Interventions

Environmental Biomarkers

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

BiomarkersBiological FactorsBiological PhenomenaEnvironmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public Health

Study Officials

  • Limeng Chen

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of the department of nephrology

Study Record Dates

First Submitted

July 25, 2022

First Posted

July 27, 2022

Study Start

July 1, 2022

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2027

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations