Effects of growth hormone treatment to patients with partial growth hormone deficiency, with special emphasis on acute phase proteins and pro-inflammatory cytokines.
- Conditions
- Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours.
- Registration Number
- EUCTR2005-004478-26-SE
- Lead Sponsor
- Karolinska universitetssjukhuset
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Verified GHD (GH secretion <3µg/L after stimulation tests) or GHI (GH secretion 3-7µg/L after stimulation tests).
2. Between 18 and 60 years old.
3. Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject).
4. Stable substitution of other hormones for a period of 6 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) no
F.1.3.1 Number of subjects for this age range
1.Known or suspected allergy to GH preparation.
2.Previous participation in this trial.
3.Participation in other clinical trials within the past three months.
4.GH treatment within the last year.
5.Malignancy or other serious diseases (ex severe cardiovascular diseases (NYHA 3-4), severe infections).
6.Sex hormone treatment initiated within the last year.
7.Expected inability to comply with trial protocol.
8.Pregnancy.
9.Lactation.
10.Diabetes mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method