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NCT Number: NCT05476627

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.

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Key information

Conditions

Chronic Kidney Diseases Body Weight Cardiovascular Diseases Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Hyperuricemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Yan Liu

CONTACT

[email protected]

+86-15811568692

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biomarkers

Diagnostic Test

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

Primary outcomes

  1. Number of Participants with End Stage Renal Disease

    Time frame: 3 years

    End Stage Renal Disease

  2. Number of Participants with Adverse cardiovascular events

    Time frame: 3 years

    Adverse cardiovascular events

  3. Number of Participants with all cause death

    Time frame: 3 years

    All cause death

Secondary outcomes

  1. Number of Participants with eGFR decline

    Time frame: 3 years

    the decline of eGFR during follow-up

  2. Number of Participants with Complications of CKD

    Time frame: 3 years

    The complications of CKD

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

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Liu

CONTACT

[email protected]

+86-15811568692

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jul 27, 2022
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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