We will evaluate the acute effects of GH on, and its relation with, cognition in healthy subjects. The present proposal focuses on the following questions:1. Does an acute rise of plasma GH levels have a (beneficial) effect on cognitive performance…
ID
Source
Brief title
Condition
- Other condition
- Hypothalamus and pituitary gland disorders
Synonym
Health condition
veroudering
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The correlation between GH and cognitive functioning, and related brain
physiology in healthy subjects.
Secondary outcome
The correlation between cortisol/ testosterone and cognitive functioning, and
related brain physiology in healthy subjects.
Background summary
Growth hormone (GH) receptors are found in the brain itself, and GH and
Insulin-like growth factor-1 (IGF-1) can cross the blood brain barrier, Several
studies have demonstrated a relationship between GH status (GH deficiency,
lower GH levels in elderly subjects) and specific cognitive functions, but no
data exist regarding acute effects of GH on cognition. The present study
proposal focuses on the acute effect of GH on cognition.
Study objective
We will evaluate the acute effects of GH on, and its relation with, cognition
in healthy subjects.
The present proposal focuses on the following questions:
1. Does an acute rise of plasma GH levels have a (beneficial) effect on
cognitive performance in healthy subjects?
2. Is GH (directly) associated with cognitive function in healthy subjects?
Study design
Double-blind randomized placebo-controlled acute intervention study on two
separate days.
Intervention
One intravenous injection with either GH releasing hormone (GHRH) or placebo.
Study burden and risks
The burden to the study subjects is the insertion of an intravenous catheter,
the injection of GHRH, blood sampling (7 x), the performance of
neuropsychological tests and registration of ERPs. The subjects will be studied
twice, each study day approximately 5 hours. There are no benefits. Study
subjects are healthy controls.
Heidelberglaan 2
3584 CS, Utrecht
NL
Heidelberglaan 2
3584 CS, Utrecht
NL
Listed location countries
Age
Inclusion criteria
- male
- age; older than 55 years old
- BMI between 20 & 33
Exclusion criteria
1. Any history of malignant disease.
2. Any history of pituitary or hypothalamic disease.
3. Any history of other central neurological disorders, including cerebrovascular infarctions, Parkinson's disease, multiple sclerosis, Alzheimer's disease.
4. Any active or recent (< 5years) psychiatric disease, including manic and depressive disorders or schizophrenia.
5. Severe cognitive deficits leading to incapacity to live independently.
6. Severe loss of vision (vision should be at least 0.5 in one eye), which is not corrected for (by glasses or lenses).
7. Any other internal condition necessitating chronic medication (subjects with well controlled hypertension, stable thyroid hormone substitution, stable hyperlipidaemia, osteoporosis, or chronic obstructive lung disease not necessitating systemic corticosteroids may be included; specific other situations can be judged by the researchers).
8. Alcohol consumption > 4 U/day.
9. Use of drugs (cannabis, cocaine, amphetamines etc.).
10. Use of medication that might affect cognitive function (e.g. benzodiazepines, antidepressants, antiepileptics, etc.).
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-005494-35-NL |
| CCMO | NL22957.041.08 |