No registrations found.
ID
Source
Brief title
Health condition
hemodialysis
(disturbed) circadian rhythm
Sponsors and support
Leo Fretz Stichting
Intervention
Outcome measures
Primary outcome
Establish 24-hr peripheral clock gene and clock controlled output gene expression profiles in blood of hemodialysis patients compared to control subjects to diagnose renal disease mediated circadian disruption.
Secondary outcome
1. Investigate the clock synchronization and phase-shifting potential of serum from chronic kidney disease patient and control groups. Renal patients are expected to have high levels of clock resetting compounds;
2. Determine the correlation between clock gene expression and sleep as a physiogical read-out of clock-driven behaviour.
Background summary
N/A
Study objective
A disruption of the biological clock is presumed in hemodialysis patients since they frequently suffer from sleep problems and lack a nocturnal melatonin surge, which is a reasonable readout for disturbed clock performance. The origin of these clinically observed disturbances is still unknown. Possibly, there is an underlying disturbed peripheral clock synchronization by constitutively high (rather than oscillating) amounts of humoral clock-resetting compounds.
Study design
24h-blood sampling:
9:00, 13:00, 17:00, 21:00, 01:00, 05:00, 09:00.
Sleep measurement (actigraphy): 4 days + nights.
Intervention
N/A
dept. Hospital Pharmacy<br>
PO Box 1502
M. Russcher
Amersfoort 3800 BM
The Netherlands
+31 (0)33 8501720
M.Russcher@meandermc.nl
dept. Hospital Pharmacy<br>
PO Box 1502
M. Russcher
Amersfoort 3800 BM
The Netherlands
+31 (0)33 8501720
M.Russcher@meandermc.nl
Inclusion criteria
Hemodialysis patients:
1. Stable chronic hemodialysis patients;
2. Written informed consent;
3. Age 18-85 years;
4. Good understanding of Dutch language.
Control patients:
1. Stable patients;
2. MDRD-GFR > 60 ml/min;
3. Age and gender matched with hemodialysis patient;
4. Written informed consent;
5. Age 18-85 years;
6. Good understanding of Dutch language.
Exclusion criteria
1. Blindness;
2. Fever >38ºC;
3. CRP > 20 mg/L;
4. Use of hypnotics during study period;
5. Anesthesia within 48 hours prior to start study measurements;
6. Serious co-morbidity that prevents participation in this study according to the investigators (e.g. neurological, psychiatric, blindness, angina, heart failure NYHA class IV).
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 |
|---|---|
| NTR-new | NL3338 |
| NTR-old | NTR3631 |
| Other | VCMO / CCMO : R12.010 / NL39856.100.12; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |