PITUITARY DAMAGE AFTER TRAUMATIC BRAIN INJURY; Occurrence of growth hormone deficiency at long term follow-up and the beneficial effects of growth hormone substitution on cardiovascular performance, quality of life and functional abilities - Growth hormone substitution in isolated growth hormone deficiency after traumatic brain injury
- Conditions
- isolated growth hormone deficiency after traumatic brain injury
- Registration Number
- EUCTR2006-005442-37-NL
- Lead Sponsor
- niversity Medical Center St Radboud, department of neurology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. The patient visits the emergency department with mild, moderate or severe traumatic brain injury. (Mild traumatic brain injury is defined as a history of impact to the head and a Glasgow Coma Scale score (GCS) 13-15 at entry in the emergency room, moderate traumatic brain injury is defined as a GCS 9-12 at entry in the emergency room, and severe traumatic brain injury is defined as a GCS <= 8 at entry in the emergency room)
2. The trauma has occurred less than 24 hours before visiting the emergency department.
3. Age = 18 years and = 65 years at the time of inclusion
4. Absolute growth hormone deficiency (defined as growth hormone response < 9 mE/l in the GHRH-arginine test), diagnosed within one of the protocols going with ABR form no. 14996 or 14998
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Age > 65 or < 18 years
2. No oral or written informed consent by patient or proxy
3. Pre-existent neuro-endocrine disorder
4. Co-existent dysfunction of pituitary axis other than the somatotropic axis
5. Instable infiltrative disease in the hypothalamus/pituitary region (eg sarcoidosis, tumour metastasis)
6. BMI >30 kg/m2
7. Primary dyslipidemia that necessitates treatment
8. Positive family history of premature cardiovascular disease
9. Overt diabetes mellitus type II (including a history of gestational diabetes mellitus)
10. Impairment in renal function (Creatinin clearance < 60 ml/min)
11. Pregnancy or wish for pregnancy during the study period, lactation
12. Retinal disease
13. Co-existent disease with decreased life expectancy, especially active malignant tumor
14. Chronic alcohol or drug abuse
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Main Objective: 1. To determine whether, in patients with a history of mild, moderate or severe TBI, a GHD is associated with an impairment in cardiovascular performance, a proatherogenic profile, a change in body composition (less free fat mass), a reduction in quality of life and an impairment in functional recovery.<br>2. To determine whether an intervention with recombinant GH has beneficial effects on the variables as mentioned under 1.;Primary end point(s): 1.Change in different components of the GHD syndrome (anthropometric characteristics, cardiovascular performance and risk profile, cognitive function and QoL), before and after GH substitution, in patients with TBI<br>2.Change in physical and neuro-cognitive factors such as Glasgow Outcome Score-extended version, not necessarily associated with GHD syndrome, before and after GH substitution, in patients with TBI <br>
- Secondary Outcome Measures
Name Time Method