No registrations found.
ID
Source
Brief title
Health condition
In English: carcinoid tumor, SSRI, selective serotonin reuptake inhibitor, serotonin, plasma, platelets, serotonin transporter.
Nederlands: carcinoïd tumor, SSRI, selectieve serotonine heropname remmers, serotonine, plasma, bloedplaatjes, serotonine transporter
Sponsors and support
Intervention
Outcome measures
Primary outcome
Analyzing whether there is a difference in the concentration dopamine and serotonin in the plasma and platelets of carcinoid tumor patients, patients using SSRI, and healthy controls.
Secondary outcome
Analyzing whether the concentration free serotonin in plasma, and the ratio free serotonin/serotonin in platelets is determined by the genotype of the serotonin transporter.
Background summary
Introduction:
Serotonin is a neurotransmitter that is responsible for several physiological processes in the body, e.g. muscle contraction, blood pressure regulation, and peripheral en central neurotransmission. The serotonin transporter (SERT) is the most important regulator of the concentration free serotonin in the plasma, because it transports serotonin from the plasma into platelets, enterochromaffin cells, and neurons, where serotonin is stored and metabolized. Serotonin also has a role in depression. Part of the patients with a carcinoid tumor produce surplus of serotonin. To investigate the correlation between free plasma serotonin and its effect on the cardiovascular system, gastrointestinal tracts, and the lungs, free serotonin in plasma has to be determined. Until now, no analytic method was available to reliably determine this concentration.
Aim:
1. To analyze the concentration dopamine and serotonin in the plasma and platelets of carcinoid tumor patients, patients using SSRI, and healthy controls;
2. To analyze the influence of the genotype of the serotonin transporter on the concentration free serotonin in plasma, and the ratio free serotonin/serotonin in platelets.
Methods:
This is a cross-sectional study. Of 30 carcinoid tumor patients, 70 patients using SSRI, and 5 healthy controls 24mL EDTA blood will be obtained. Dopamine, and serotonin in plasma and platelets, and the genotype of the serotonin transporter will be determined.
Study objective
1. The concentrations serotonin and dopamine are different between carcinoid tumor patients, patients using SSRI, and healthy controls;
2. The concentration free serotonin in plasma, and the ratio free serotonin/serotonin in platelets is determined by the genotype of the serotonin transporter.
Study design
This is a cross-sectional study: At one time point 24mL EDTA blood will be obtained.
Intervention
No intervention: At one time point 24mL EDTA blood will be obtained from the patient.
CMC IV, Y2.119, EA61<br>
Postbus 30001
W.H.A. Jong, de
Groningen 9700 RB
The Netherlands
+31 (0)50 3617015
w.h.a.de.jong@umcg.nl
CMC IV, Y2.119, EA61<br>
Postbus 30001
W.H.A. Jong, de
Groningen 9700 RB
The Netherlands
+31 (0)50 3617015
w.h.a.de.jong@umcg.nl
Inclusion criteria
Ethics:
1. Approval of the METC UMCG;
2. Written informed consent.
Participants:
1. Healthy men or women;
2. Patients with a metastasized carcinoid tumor, that produces serotonin;
3. Patients with a depression or anxiety disorder, which use selective serotonin reuptake inhibitors:
A. The diagnosis is based on the judgement of the patient's current doctor;
B. The depression/anxiety disorder can be present or in remission;
C. Treatment with SSRI should be at least 6 weeks, and the dose should be suitable (citalopram 20mg; escitalopram 10mg; fluvoxamine 100mg; fluoxetine 20mg; paroxetine 20mg; sertraline 50mg).
Exclusion criteria
1. The use of medication that interferes with the serotonin metabolism or serotonin reuptake (exception: use of SSRI in patients with depression/anxiety disorder), for example aspirin, psychofarmaca (other than SSRI (TCA, MAO-inhibitors, mirtazapine, bupropion, venlafaxine, duloxetine), anxiolytics, antipsychotics, and anticonvulsants;
2. Drug abuse (8 weeks prior to inclusion);
3. Alcohol abuse (8 weeks prior to inclusion: females: >14 glasses a week, males: >21 glasses a week);
4. Consumption of walnuts or bananas 48 hours prior to obtaining of blood sample.
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 | NL3241 |
| NTR-old | NTR3393 |
| Other | METC UMCG : 2009/171 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |