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

Phase 4

Conditions: 10042258
traumatologische aandoeningen
growth hormone deficiency after head injury
traumatic brain injury-induced growth hormone deficiency
10021112

Registration Number: NL-OMON30305

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

1. Age > 65 or < 18 years
2. No oral or written informed consent by patient
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. History of neoplasmata
14. Co-existent disease with decreased life expectancy, especially active malignant tumor
15. Chronic alcohol or drug abuse

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. change in different components of the GHD syndrome, before and after GH<br /><br>substitution, in patients with TBI<br /><br>2. change in physical and neuro-cognitive factors, not necessarily associated<br /><br>with GHD syndrome, before and after GH substitution, in patients with TBI</p><br>

Secondary Outcome Measures