Patients with adult-onset growth hormone deficiency and the presence of atherosclerotic disease in the coronary arteries
Conditions
Interventions
Trade Name: Genotropin
Product Name: genotropin
Product Code: RVG 15790 or RVG 25480
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
Radboud University Nijmegen Medical Centre, Department of Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Biochemically proven GH deficiency 2. Age between 35 and 60 years 3. GH deficient within half a year of neurosurgical procedure or GH deficient at least 5 years 4. Optimal substitution of other hormones 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
Exclusion criteria
Exclusion criteria: 1. BMI >30 2. Positive history of myocardial or valve or coronary disease or symptoms that suggest coronary disease (chest pain in rest or during exercise) 3. Rhythm disturbances 4. Moderate or severe pulmonary disease 5. Impairment in renal function (Creatinin clearance < 60 ml/min) 6. Positive family history of primary dyslipidemia 7. Positive family history from premature cardiovascular disease 8. Positive family history of diabetes type II 9. Allergy for contrast 10. Claustrophobia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Hypothesis: 1. Patients who suffer from a hypopituitarism and an adult-onset growth hormone deficiency (AGHD) express more atherosclerotic disease in the coronary system (compared with a historically formed control subjects, present as a database in the cardiology department from the UMC Utrecht) 2. Atherosclerotic disease in the coronary system wil be in regression after one year substitution with recombinant human growth hormone (in line with previously published results with regard to carotid IMT) ;Secondary Objective: Patients with a hypopituitarism and AGHD display additional proatherogenic mechanisms: 2.1 disturbances in antioxidant capacity of the high-density lipoprotein (HDL) fraction, 2.2 disturbances in the differentiation of endothelial progenitor cells with a less capacity to repair damaged endothelium, 2.3 an increase of metalloproteinases as part of the pro-inflammatory profile in circulation . ;Primary end point(s): 1. Presence of atherosclerotic disease in the coronary system (scored in an established (blinded) protocol as the level of stenosis within coronary segments and the level of intracoronary calcium) | — |
Countries
Netherlands
Outcome results
None listed