Increasing kidney function by kidney transplantation might improve the circadian rhythms of melatonin concentration, sleep and 24-hour blood pressure profile.
ID
Bron
Verkorte titel
Aandoening
kidney transplantation
circadian rhythm
sleep disturbances
ambulatory blood pressure
Dutch: niertransplantatie, circadiane ritmiek, slaapstoornissen, 24u-bloeddruk
Ondersteuning
Meander Medical Centre, Amersfoort, The Netherlands
Meander Medical Centre, Amersfoort, The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Recurrence of the 'dim light melatonin onset' (DLMO) after kidney transplantation in kidney transplant recipients. Definition of the DLMO: melatonin concentration peak >4 pg/ml saliva, between 7 and 12 pm.
Achtergrond van het onderzoek
Monocentre study, VU University Medical Centre, Amersfoort, The Netherlands.
Doel van het onderzoek
Increasing kidney function by kidney transplantation might improve the circadian rhythms of melatonin concentration, sleep and 24-hour blood pressure profile.
Onderzoeksopzet
Kidney recipients:
1. DLMO (salivary melatonin concentration), ESS (subjective sleep), actigraphy (objective sleep): measured at baseline, 14 days after Tx and 3 months after Tx;
2. MOS-SF36, 24-hour body temperature and 24-hour ambulatory blood pressure measurement are taken at baseline and 3 months after Tx.
Kidney donors:
1. DLMO (salivary melatonin concentration), ESS (subjective sleep), actigraphy (objective sleep), MOS-SF36, 24-hour body temperature and 24-hour ambulatory blood pressure measurement are taken at baseline and 3 months after Tx.
Onderzoeksproduct en/of interventie
The course of the circadian rhythms of melatonin, ambulatory blood pressure, body temperature and sleep are measured in kidney transplant recipients and their living kidney donors before and after kidney transplantation (Tx). A sleep questionnaire (Epworth Sleepiness Scale, ESS) and quality of life questionnaire (MOS-SF36) are taken at baseline and after transplantation.
Publiek
dept. Hospital Pharmacy<br>
PO Box 1502
M. Russcher
Amersfoort 3800 BM
The Netherlands
+31 (0)33 8501720
M.Russcher@meandermc.nl
Wetenschappelijk
dept. Hospital Pharmacy<br>
PO Box 1502
M. Russcher
Amersfoort 3800 BM
The Netherlands
+31 (0)33 8501720
M.Russcher@meandermc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Kidney recipients:
1. Aged 18-85 yr, both male and female;
2. Living donor transplantation;
3. Good understanding of dutch language;
4. Informed consent.
Kidney donors:
1. Aged 18-85 yr, both male and female;
2. Good understanding of dutch language;
3. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Both recipients and donors:
1. Use of hypnotics/melatonin during study measurements;
2. Relevant co-morbidity that interferes with participation in the study according to the investigators (e.g. heart failure NYHA class IV, instable AP, pulmonary, psychiatric, neurologic, blindness);
3. Documented sleep apnea;
4. Alcohol / drug abuse.
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2833 |
| NTR-old | NTR2974 |
| Ander register | METc VUmc // ABR number : 210/253 // NL31617.029.10; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |