NL-OMON30305
Not yet recruiting
Phase 4
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 TBI
niversitair Medisch Centrum Sint Radboud0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- traumatologische aandoeningen
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 50
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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