The effects of kidney transplantation on circadian rhythm. Focus on sleep and cardiometabolic risks.

Completed

• Conditions: circadian rhythm; kidney transplantation; 10040991; 10038430

• Registration Number: NL-OMON34859
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Kidney recipients:
- aged 18-85 yr
- living donor transplantation
- good understanding of dutch language
- informed consent;Kidney donors:
- aged 18-85 yr
- good understanding of dutch language
- informed consent

Exclusion Criteria

- use of hypnotics/melatonin during the study
- relevant co-morbidity that interferes with participation in the study (e.g. heart failure NYHA class IV, instable AP, pulmonary, psychiatric, neurogic, blindness)
- documented sleep apnea
- alcohol / drug abuse

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: recurrence of the 'dim light melatonin onset (DLMO)' after<br /><br>kidney transplantation. Definition of the DLMO: melatonin concentration peak >4<br /><br>pg/ml in saliva, between 7 and 12 pm.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are: changes in objective and subjective sleep parameters,<br /><br>changes in circadian body temperature, ambulant blood pressure profile,<br /><br>cardiometabolic parameters and quality of life.</p><br>