Advanced Glycation Endproducts (AGEs) and their impact on transport proteins, inflammation and body composition of hemodialysis patients compared to healthy subjects

Recruiting

• Conditions: healthy subjects for comparison; N18.5; Chronic kidney disease, stage 5

• Registration Number: DRKS00033331
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg, Universitätsmedizin Halle, Klinik für Innere Medizin II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

a) healthy subjects (Group A, young people)
- Age: > 18 to 30 years inclusive
- written informed consent

b) healthy subjects (Group B, moderate old people)
- Age: > 40 to 70 years inclusive
- written informed consent

c) moderate old hemodialysis patients (Group C)
- Age: > 40 to 70 years inclusive
- written informed consent
- endstage renal disease, hemodialysis therapy for at least 3 months

Exclusion Criteria

a) healthy subjects (Group A, young people)
- known malignant tumor disease
- impaired kidney function (eGFR < 60 ml/min)
- acute infection (CRP > 50mg/l, fever, chills)
- Diabetes mellitus (HbA1c < 40 mmol/mol IFCC)
- psychiatric or neurological illnesses that impair the ability to consent
- known pregnancy or lack of contraception (premenopausal women)

b) healthy subjects (Group B, moderate old people)
- known malignant tumor disease
- impaired kidney function (eGFR < 60 ml/min)
- acute infection (CRP > 50mg/l, fever, chills)
- Diabetes mellitus (HbA1c < 40 mmol/mol IFCC)
- psychiatric or neurological illnesses that impair the ability to consent
- known pregnancy or lack of contraception (premenopausal women)

c) moderate old hemodialysis patients (Group C)
- known malignant tumor disease
- acute infection (CRP > 50mg/l, fever, chills)
- Diabetes mellitus (HbA1c < 40 mmol/mol IFCC)
- psychiatric or neurological illnesses that impair the ability to consent
- known pregnancy or lack of contraception (premenopausal women)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is to examine the difference in AGE-contaminated transport proteins between hemodialysis patients and an age-matched group of healthy volunteers. The evaluation is carried out using descriptive statistics and correlation respectively.

Secondary Outcome Measures

Name	Time	Method
The following are taken into account as secondary endpoints:<br>- difference in AGE-contaminated transport proteins in the healthy control group compared to a younger control group<br>- correlation of AGE concentrations with parameters of the inflammatory/anti-inflammatory axis (IL-6, IL-10)<br>- influence of AGE exposure on the regulation of the inflammatory cascade (measurement of microRNAs: miR-142-3p and miR-142-5p)<br>- differences in bioelectrically determined nutritional parameters between the examined groups<br>- correlation of bioelectrical impedance analysis with the AGE load of the transport proteins and the inflammatory markers.