Primary Objective: - What influence has kidney transplantation on (recovery of) melatonin production?Secondary Objective(s): - Is recovery of melatonin rhythm after kidney transplantation related to improvement of other circadian rhythms, e.g. body…
ID
Source
Brief title
Condition
- Sleep disorders and disturbances
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Previous research has revealed that sleep and melatonin rhythm are often
disturbed in patients with chronic renal failure. In a pilot project (n=7) we
have shown that melatonin rhythm had improved in some patients after kidney
transplantation compared to when they were still on hemodialysis. However, in
others it had not improved. This led to the design of this study in which we
will observe a larger group of end-stage-renal-failure patients that will
receive a kidney transplant and their kidney donors to objectify the effect of
kidney transplantation on sleep, melatonin production, body temperature and
blood pressure. Possible correlations between changes in melatonin production
and other effects such as blood pressure and sleep will be addressed.
Study objective
Primary Objective:
- What influence has kidney transplantation on (recovery of) melatonin
production?
Secondary Objective(s):
- Is recovery of melatonin rhythm after kidney transplantation related to
improvement of other circadian rhythms, e.g. body temperature and ambulant
blood pressure?
- Is recovery of melatonin rhythm after kidney transplantation related to
improvement of cardiovascular intermediate endpoints, e.g. blood pressure
dipping profile, IL-6 and hsCRP levels?
- Is recovery of melatonin rhythm after kidney transplantation related to
improvement in sleep-wake rhythm and quality of life?
Study design
longitudinal observational study
Study burden and risks
Measurements in kidney recipients take place at 1 month before transplantation,
2 weeks and 3 months after transplantation.
Measurements in kidney donors take place at 1 month before transplantation and
3 months after transplantation.
Kidney recipients:
- 3x objective sleep registration by actigraphy
- 3x saliva sampling for measuring melatonin curves
- 3x sleep questionnaire (Epworth Sleepiness Scale)
- 3x quality of life questionnaire (MOS-SF36)
- 2x 24-hr blood pressure measurement
- 3x venipuncture
- 2x body temperature measurement
Kidney donors:
- 2x objective sleep registration by actigraphy
- 2x saliva sampling for measuring melatonin curves
- 2x sleep questionnaire (Epworth Sleepiness Scale)
- 2x quality of life questionnaire (MOS-SF36)
- 2x 24-hr blood pressure measurement
- 2x venipuncture
- 2x body temperature measurement
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31617.029.10 |