Chronic treatment with glucocorticoids (GCs) regardless of indication leads to marked protein catabolism that causes substantial debilitation which includes muscle wasting, weakness, skin fragility, bruising, poor wound healing and osteoporosis. The selection of subjects is therefore patients with polymyalgia rheumatica or inflammatory arthitis receiving long-term GC treatment.
Conditions
Interventions
Trade Name: Genotropin
Product Name: Genotropin
Pharmaceutical Form: Solution for injection
Trade Name: Testogel
Product Name: Testogel
Pharmaceutical Form: Gel
Sponsors
VästraGötaland
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: · 12 men with polymyalgia rheumatica or inflammatory arthritis in remission > 6 months Age 50-80 yr. Body mass index 20-30 kg/m2 Glucocorticoid therapy for > 12 months Stable dose of prednisolone of between 5-10 mg/day during > 3 months Written informed consent of the patient 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
Exclusion criteria: Diabetes mellitus Congestive heart failure Significant hepatic dysfunction with persistent elevation of transaminases >2 x upper limit of normal Significant renal dysfunction with serum creatinine > 150 micromol/L History of cancer Patients needing assistance in activity of daily life Any other hormonal treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoints of the study are changes in protein breakdown, protein oxidation and protein synthesis.;Main Objective: The primary aim of this protocol is to investigate whether GH or androgen in long-term users of glucocorticoid treatment can achieve protein anabolism. The hypothesises behind this protocol are that in patients on long-term glucocorticoid treatment: GH can increase protein synthesis and reduce protein oxidation and thereof achieve protein anabolism. Androgen treatment alone can induce protein anabolism. Combined androgen and GH treatment can have a synergistic effect on protein metabolism. ;Secondary Objective: To establish whether protein anabolism can be amplified by combined GH and androgen treatment in long-term glucocorticoid users compared with either treatment alone To study the effects of GH treatment alone and in combination with a low androgen dose on: · Protein metabolism · Energy expenditure and fat oxidation. · Serum markers of GH action · Glucose tolerance | — |
Countries
Sweden
Outcome results
None listed