To compare free testosterone levels between male CCH patients and healthy controls Secondary Objectives: To compare differences in androstenedione, DHEA, DHT and 11oxC19 level, testosterone/estrogen ratio, activin level, inhibin level and morning…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in free testosterone between CCH patients versus healthy controls
Secondary outcome
Differences between androstenedione, DHEA, DHT and 11oxC19 steroids levels,
testosterone/estrogen ratio, activin level*, inhibin** level and morning
cortisol level in blood and 6-sulfatoxymelatonin level in nocturnal urine
between:
- All cluster headache groups (ECH patients in bout, ECH patients out of bout
and CCH patients)
- All ECH patients (in an episode and outside an episode) versus healthy
controls
*Inhibin and 11OXC19 levels will be measured only if a difference in
testosterone is observed between groups.
**Activin levels will not be measured if no difference in testosterone and LH
is observed between groups.
Background summary
Cluster headache is a very severe primary headache disorder for which the cause
remains unknown. Interestingly, cluster headache attacks often appear at night,
one hour after falling asleep, suggesting a link with sleep and the biological
clock, residing in the suprachiasmatic nucleus of the hypothalamus. Melatonin
is produced in the suprachiasmatic nucleus and is closely related to the
sleep-wake cycle and the circadian rhythm. Previous studies indicate a lower
melatonin production in cluster headache patients. Cluster headache was always
considered a *male* disease, although male:female ratio appears to be
declining, most likely due to better diagnosis amongst woman. Despite this
declining ratio, males are still heavily overrepresented in cluster headache
with an estimated male:female ratio of 2:1. Surprisingly, several small scale
studies reported lower testosterone levels in male cluster headache patients.
We hypothesize that hormone levels in chronic cluster headache patients will be
the most severe affected compared to episodic cluster headache patients and
healthy controls.
Study objective
To compare free testosterone levels between male CCH patients and healthy
controls
Secondary Objectives:
To compare differences in androstenedione, DHEA, DHT and 11oxC19 level,
testosterone/estrogen ratio, activin level, inhibin level and morning cortisol
level in blood and 6-sulfatoxymelatonin level in nocturnal urine between:
- All cluster headache groups (ECH patients in bout, ECH patients out of bout
and CCH patients)
- All ECH patients (in an episode and outside an episode) versus healthy
controls
Study design
Cross-sectional with a longitudinal aspect in episodic cluster headache
patients.
Study burden and risks
The burden and risks associated with this study are very low. Only one
container of blood will be taken through a single vena punction. Episodic
cluster headache patients will be tested twice: inside and outside the cluster
bout. Furthermore, participants are instructed to collect overnight urine one
night.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Male
- Subjects need to be 18 years or older
- Diagnosed with cluster headache (episodic or chronic) or no headache
diagnosis
Exclusion criteria
- Subjects are not allowed to use steroid or melatonin suppletion
- Diagnosis of migraine
- Disease effecting hormonal regulation
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL74876.058.20 |