The assessment of microvascular alterations in renal-pancreas transplant recipients before and after transplantation.

Recruiting

• Conditions: diabetic nephropathy; kidney-pancreas transplantation; 10012653; 10038430

• Registration Number: NL-OMON33101
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Age: 18 -70 years
2. Female or male
3. Kidney-pancreas transplantation
4. Patients must be able to adhere to the study visit schedule and protocol requirements.
5. Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.

Exclusion Criteria

1. Patients with evidence of active infection or abcesses
2. Patients suffering from hepatic failure.
3. Patients suffering from an active autoimmune disease
4. Patients with epilepsy
5. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
6. Subjects who currently have an active opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Non- invasive assessment of microvascular structure in diabetic nephropathy<br /><br>patients before and after kidney-pancreas transplantation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1.Does kidney-pancreas transplantation improve microvascular damage assessed by<br />OPS?<br />2.Does OPS correlate with serum and urine markers for fibrosis and endothelial<br />dysfunction in these patients?</p>