Study on the relationship between clinical features and kidney pathology in type 2 diabetes
Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
This study is trying to see how the symptoms of kidney problems in people with type 2 diabetes differ from those with other kidney diseases to help improve treatment and understanding of diabetic kidney disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT03865914 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the differences in clinical phenotypes between diabetic nephropathy and non-diabetic renal diseases in patients with type 2 diabetes mellitus. It will analyze the correlation between clinical features and pathological findings to establish criteria for clinical staging and prognosis of diabetic kidney disease. The study will include patients who have undergone renal biopsy and have a confirmed diagnosis of type 2 diabetes with renal impairment. By clarifying these relationships, the study seeks to improve the understanding and management of diabetic kidney disease.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with type 2 diabetes and experiencing renal impairment.
Not a fit: Patients with incomplete medical histories, secondary renal diseases, hereditary kidney diseases, autoimmune diseases, or those with a prognosis of less than 6 months due to malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic criteria and treatment strategies for patients with diabetic kidney disease.
How similar studies have performed: While there is ongoing research in this area, this study's specific focus on the correlation between clinical phenotype and pathology in type 2 diabetic nephropathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥18, male or female * Clinical diagnosed as type 2 diabetes mellitus * The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency * The renal biopsy was performed with complete renal pathological diagnosis * Obtaining the signed informed consent from patients Exclusion Criteria: * The history of the disease was not complete * Clinical diagnosed as other secondary renal diseases * Patients with hereditary kidney disease * Autoimmune diseases * Patients with malignant tumor were expected to survive less than 6 months * Pregnancy and lactation
Where this trial is running
Beijing, Beijing Municipality
- Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xiangmei Chen, MD.&Ph.D — Chinese PLA General Hospital
- Study coordinator: Xiangmei Chen, MD.&Ph.D
- Email: xmchen301@126.com
- Phone: +86 010 66935462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.