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Hypothalame serotonine transsporters in mensen verdacht voor hypothalame schade.


- candidate number8466
- NTR NumberNTR2520
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-sep-2010
- Secondary IDs10/132 METC AMC
- Public TitleHypothalame serotonine transsporters in mensen verdacht voor hypothalame schade.
- Scientific TitleHypothalamic serotonin transporters in subjects suspect for hypothalamic damage.
- ACRONYMHypS-Study
- hypothesisWe hypothesize that subjects suffering from hypothalamic dysfunction may have a hyposerotonergic neurotransmission. Therefore we will investigate if there are differences in specific hypothalamic-to-nonspecific [123I]FP-CIT binding ratios using SPECT in subjects with hypopituitarism and clinical suspicion of hypothalamic dysfunction compared to subjects with pituitary insufficiency but no clinical suspicion of hypothalamic damage and healthy age- and gender-matched controls.
- Healt Condition(s) or Problem(s) studiedHypothalamic dysfunction, Hypothalamic damage, Pituitary insufficiency
- Inclusion criteria1. Having pituitary insufficiency and suspicion of hypothalamic damage OR having pituitary insufficiency without suspicion of hypothalamic damage OR (in case of controls) being healthy;
2. Age between 18-75 years old.
- Exclusion criteria1. Unwilling or unable to provide informed consent;
2. Serious neuropsychiatric problems;
3. Use of medication which interferes with serotonin metabolism (e.g. psychotropic medication like SSRIs or other antidepressants) and dopamin metabolism;
4. Life-time ecstasy, amphetamine or cocaine use;
5. Intravenous drug abuse;
6. Participation in another study associated with exposure to ionizinf radiation during the last 12 months;
7. Pregnancy;
8. Contra-indications for MRI.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 22-sep-2010
- planned closingdate31-dec-2011
- Target number of participants18
- InterventionsN/A
- Primary outcomeDifferences in binding ratio (hypothalamus to occipital cortex/cerebellum) of the radioligand [123I]FP-CIT to serotonin transporters in the hypothalamus in subjects with hypopituitarism and clinical suspicion of hypothalamic dysfunction compared to subjects with pituitary insufficiency but no clinical suspicion of hypothalamic damage and healthy age- and gender-matched controls.
- Secondary outcomeThe optimal time-point to assess central serotonin transporter binding with FP-CIT SPECT after injection of the radiotracer.
- Timepoints1, 2 and 3 hours after administering of approximately 110 MBq [123I]FP-CIT.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.J.F. Borgers
- CONTACT for SCIENTIFIC QUERIESDr. P.H.L.T. Bisschop
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryPituitary insufficiency is associated with sleep disturbances, metabolic abnormalities and a decreased quality of life despite proper hormonal substitution. The pituitary is both anatomically and functionally closely related to the hypothalamus, a highly organized part of the brain that plays a crucial role in many homeostatic processes including sleep-wake rhythm, energy metabolism, body temperature regulation and activity of the autonomic nervous system. Because the disorders associated with pituitary insufficiency show many similarities with the diverse functions of the hypothalamus, hypothalamic dysfunction may be involved in the pathophysiology of these disorders. Until recently, no diagnostic tools have been available to confirm hypothalamic dysfunction in these patients.
Recent developments in radionucleotide imaging of brain have enabled visualisation of serotonin transport in the human hypothalamus in vivo. Serotonin plays a very important role in the regulation of the hypothalamic functions. We hypothesize that patients suffering from hypothalamic dysfunction may have a hyposerotonergic neurotransmission.
Therefore, we will investigate if there are differences in serotonin transporters in the hypothalamus in subjects with hypopituitarism and clinical suspicion of hypothalamic dysfunction compared to subjects with pituitary insufficiency but no clinical suspicion of hypothalamic damage and healthy age- and gender-matched controls.
- Main changes (audit trail)
- RECORD17-sep-2010 - 8-okt-2010


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