Identifying MicroRNA Biomarkers of Obesity-Associated Renal Disease after Living Kidney Donatio

Recruiting

• Conditions: obesitas; Kidneyfailure; Obesity-Associated Renal Disease; 10013317; 10038430

• Registration Number: NL-OMON39270
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 650

Inclusion Criteria

All former living kidney donors who donated a kidney since 1968 at the Leiden University Medical Center (aproximate n<=650).

Exclusion Criteria

Patients will be excluded from analyses if their medical history or the oral glucose tolerance test (OGTT) at the day of assessment reveals presence of diabetes mellitus.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The main outcome parameter will be a top-5 of differentially expressed miRs in<br /><br>plasma and urine between obese progressors to albuminuria versus<br /><br>non-progressors, adjusted for miRs associated with progression to albuminuria<br /><br>not related to obesity.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- albuminuria from 24h urine<br /><br>- renal function as assessed by 24h urinary creatinine clearance<br /><br>- anthropometric measures of obesity (BMI, waist/hip ratio)<br /><br>- fasting glucose and post OGTT glucose<br /><br>- automated blood pressure (dynamap)<br /><br>- non-invasive assessment of microcirculation using orthogonal polarization<br /><br>spectral (OPS) imaging of oral mucosa.<br /><br>- serum/plasma parameters of obesity-associated parameters of inflammation<br /><br>(hsCRP), endothelial dysfunction (sICAM-1, sVCAM-1, sE-Selectine) and<br /><br>coagulation (PA1-1)<br /><br>- smoking history, alcohol use<br /><br>- medication including hormonal replacement therapy in women<br /><br>- medical history / record review for cardiovascular history and/or de novo<br /><br>renal disease.</p><br>