To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiency

• Register: EUCTR
• Last refreshed on: 20 May 2013
• Main ID: EUCTR2012-005066-36-NL
• Date of registration: 23/01/2013
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center
• Public title: To investigate the effect of different doses of Growth Hormone treatment on the risk of developing cardiovascular diseases in patients with growth hormone deficiency
• Scientific title: Effect of Growth Hormone replacement therapy on cardiovascular risk factors in adult patients with severe growth hormone deficiency: association with IGF-I concentration - GH and cardiovascular risk factors
• Date of first enrolment: 15/05/2013
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005066-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Netherlands

Contacts

• Name: Investigator
• Affiliation: VU University Medical Center

• Name: Investigator
• Affiliation: VU University Medical Center

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Growth hormone deficiency

Intervention(s)

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 Name: Humatrope
Pharmaceutical Form: Concentrate and solvent for solution for injection

Trade Name: Zomacton
Pharmaceutical Form: Concentrate and solvent for solution for injection

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Baseline (treated), after four months of withdrawal, and after four months of adjusted treatment

Main Objective: Cardiovascular risk factors (main objectives: body composition and lipid profile)

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.

Secondary Outcome(s)

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

Secondary ID(s)

12-17

Source(s) of Monetary Support

ZonMW

Divisie I Beheer B.V. VUmc