Patients with various degrees of growth hormone (GH) insufficiency due to previously operated pituitary tumours.
Conditions
Interventions
Trade Name: Norditropin SimpleXx
Product Name: Norditropin SimpleXx
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somatropin
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Karolinska universitetssjukhuset
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Verified GHD (GH secretion =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the impact of growth hormone (GH) treatment in adults with GH insufficiency on inflammatory parameters, lipids and body composition.;Secondary Objective: To study changes in blood lipids (PAI-1, triglycerides, total-, HDL- and LDL-cholesterol and Lp(a)). To study changes in quality of life (PGW). Safety ;Primary end point(s): Changes in inflammatory parameters (IL-6, TNF-a, CRP, Leptin and Adiponektin), comparing measurements at baseline and 6 months. Changes in body composition (lean body mass and fat mass) measured by dual en-ergy X-ray absorptiometry (DEXA), comparing measurements at baseline and 6 months. | — |
Countries
Sweden
Outcome results
None listed