Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.
This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET). Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
1.25 mg, 6 months
Equivalent to 1.25 mg, 6 months
Healthy controls
Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, DK, Denmark
Body composition: fat mass and lean body mass
Time frame: 6 months + 18 months
Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
Time frame: 6 months
Heart function evaluated by echocardiography (conventional and tissue doppler)
Time frame: 6 months + 18 months
Lipid profile
Time frame: 6 months + 18 months
24 hour ambulatory blood pressure
Time frame: 6 months + 18 months
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