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Clinical study of simultaneous pancreas and kidney transplantation on improving brain structure and function in diabetic end-stage renal disease patients

Clinical study of simultaneous pancreas and kidney transplantation on improving brain structure and function in diabetic end-stage renal disease patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100143
Enrollment
Unknown
Registered
2025-04-03
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End stage diabetes nephropathy

Interventions

End-stage renal disease treated with renal transplantation alone:NA
Healthy control group:NA
Diabetes mellitus combined with end-stage renal disease and treated with combined pancreas-kidney transplantation:NA

Sponsors

Second Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The experimental group was the recipient who receive simultaneous pancreas-kidney transplantation from donation after citizen's death. Control group 1 is the recipient of allogeneic kidney transplantation from donation after citizen's death. Control group 2 is healthy people who have not undergone transplantation; 2. Subjects understand the purpose and risks of the study and are willing to participate in the study and give written informed consent; 3. 18~65 years old, male or female; 4. ABO blood group matching between donor and recipient; 5. Peak PRA < 10%;

Exclusion criteria

Exclusion criteria: 1. The subject has already received organ transplantation; 2. ABO blood group incompatible or T-cell crossmatch positive between donor and recipient; 3. The cold ischemia time of the graft is more than 24 hours; 4. Pre-existing changes in brain function due to non-diabetic factors, such as craniocerebral trauma, cerebrovascular malformations, dementia, and severe cognitive impairment; 5. Poor compliance; 6. Pregnant or breastfeeding women, and women of childbearing age who do not wish to receive contraception; 7. Transplant recipients or donors who are seropositive for HIV; 8. Active systemic infection requiring antibiotic treatment; 9. The patient has a malignant tumour or a history of malignant tumour within the past 5 years, except for non-metastatic basal cell carcinoma of the skin, squamous cell carcinoma, and cervical carcinoma in situ, which have been successfully treated; 10. Subjects with medical or psychiatric conditions affecting compliance;

Design outcomes

Primary

MeasureTime frame
Gray matter volume of the brain;Regional cortical thickness;Montreal Cognitive Assessment score;

Countries

China

Contacts

Public ContactZhang Peng

Second Affiliated Hospital of Guangzhou Medical University

410313386@qq.com+86 20 39195869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026