Growth hormone deficiency
Conditions
Interventions
Trade Name: Genotropin
Pharmaceutical Form: Concentrate and solvent for solution for injection
Trade Name: Norditropin
Pharmaceutical Form: Concentrate and solvent for solution for injection
Trade N
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Ongoing surveillance at our centre (VUmc, Amsterdam) - GH treated (at least one year) - Men and women with an age between 20 and 65 years, both childhood as adult onset GHD - Stable substitution therapies for other pituitary hormone deficiencies 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 32 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects with a craniopharyngioma as cause of their GHD or pituitary deficiencies - Contraindications for the use of Growth Hormone treatment - (Receiving treatment for) malignant disease (in the past) - Cardiovascular event less than one year prior to inclusion - Participation in other studies - Subjects, who in the opinion of the investigator, are unsuitable in any other way to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cardiovascular risk factors (main objectives: body composition and lipid profile);Secondary Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid profile; secondary objectives: remainder) we investigate the effect on glucose metabolism, physical performance, and neuropsychological functioning of different levels of IGF-I ;Primary end point(s): Cardiovascular risk factors (main objectives: body composition and lipid profile). Body composition will primarily be measured as waist/hip ratio and lipid profile as total cholesterol. ;Timepoint(s) of evaluation of this end point: Baseline (treated), after four months of withdrawal, and after four months of adjusted treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cardiovascular risk factors include other measurements of body composition and lipid profile, inflammatory markers, PWV, FMD, microvascular function, and the presence of the metabolic syndrome. Physical performance will be measured as muscle strength, function and physical activity. Glucose metabolism will be measured as fasting and two-hour postprandial glucose measurements, insulin and insulin resistance calculated by HOMA. Neuropsychological functioning includes quality of life, cognition, and mood. Quality of life will be assessed by a disease specific questionnaire and a general questionnaire for quality of life. Cognitive function will be tested by different tasks for visual memory and executive function. Mood will be assessed by a questionnaire addressing depression, anger, fatigue, tension, and vigor. Outcome of the different measurements for cardiovascular risk, physical performance, glucose metabolism, and neuropsychological functioning will be compared by gender. ;Timepoint(s) of evaluation of this end point: Baseline (treated), after four months of withdrawal, and after four months of adjusted treatment | — |
Countries
Netherlands
Contacts
Public ContactInvestigator
VU University Medical Center
Outcome results
None listed