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

The effects of kidney transplantation on circadian rhythm. Focus on sleep and cardiometabolic risks. - Circadian Rhythm In Kidney Transplantation -01 (CRIKT-01)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34859
Enrollment
60
Registered
2011-01-11
Start date
2011-04-27
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

circadian rhythm kidney transplantation

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Secondary outcomes are: changes in objective and subjective sleep parameters, changes in circadian body temperature, ambulant blood pressure profile, cardiometabolic parameters and quality of life.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)