A study to determine the effects of growth hormone (GH) replacement therapy on quality of life and cardiovascualr risk in GH deficient adults - Growth Hormone and Quality of Life (GroH-QoL)
- Conditions
- Growth hormone deficiency in adult life
- Registration Number
- EUCTR2004-004835-72-GB
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Aged over 18
Able to provide informed consent
Severe GH deficiency in adult life
No GH replacement for six months
Other hormone therapy stable over preceding six months
Life expectancy > 15 months
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Active malignant disease
Active Cushing's disease or active acromegaly
Pregnancy
Breast feeding
Proliferative diabetic retinopathy
Sensitivity to GH or it preservative
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the impact of growth hormone replacement therapy on quality of Life in adults with severe growth hormone deficiency;Secondary Objective: To determine the impact of growth hormone replacement therapy on markers of cardiovascualr risk and bone density in adults with severe growth hormone deficiency;Primary end point(s): Quality of life determined using the Quality of Life Adult Growth Hormone Deficiency Assessment (QoL-AGHDA)
- Secondary Outcome Measures
Name Time Method