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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05476627
Collaborator
(none)
200
1
60
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Biomarkers

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2027

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with End Stage Renal Disease [3 years]

    End Stage Renal Disease

  2. Number of Participants with Adverse cardiovascular events [3 years]

    Adverse cardiovascular events

  3. Number of Participants with all cause death [3 years]

    All cause death

Secondary Outcome Measures

  1. Number of Participants with eGFR decline [3 years]

    the decline of eGFR during follow-up

  2. Number of Participants with Complications of CKD [3 years]

    The complications of CKD

  3. Life quality assessment with short form-36 (SF-36) [3 years]

    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.

  4. Advanced Intelligence Assessment with Mini-Mental State Examination (MMSE) [3 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Limeng Chen, director of the department of nephrology, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05476627
Other Study ID Numbers:
  • JS-2136
First Posted:
Jul 27, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Limeng Chen, director of the department of nephrology, Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2022