Metabolic health profile in young adults with Prader-Willi syndrome: Results of a 2-year randomised, placebo-controlled, cross-over GH trial.

ContextPatients with Prader-Willi syndrome (PWS) have an increased fat mass and decreased lean body mass. GH-treated young adults with PWS who have attained adult height benefit from continuation of growth hormone (GH) treatment, as GH maintained their improved body composition, whereas fat mass increased during the placebo period. Adults with PWS are predisposed to T2DM and cardiovascular disease. Whether GH affects metabolic health profile of this patient group is unknown. ObjectiveTo investigate the effects of GHvs placebo on metabolic health, in young adults with PWS who were GH-treated for many years during childhood and had attained adult height (AH). MethodA 2-year, randomized, double-blind, placebo-controlled crossover study with stratification for gender and BMI in 27 young adults with PWS. Intervention with GH (067 mg/m(2)/day) and placebo, both for 1-year duration. ResultsCompared to placebo, GH treatment resulted in similar glucose and insulin levels during oral glucose tolerance test. Only fasting glucose and insulin were slightly higher during GHvs placebo (+02 mmol/l and +184 pmol/l), although both remained within normal ranges in both phases. Blood pressure and lipid profile were similar after GHvs placebo. At baseline (AH) and during GH, no patients had metabolic syndrome, while 1 developed it during placebo treatment. ConclusionsGrowth hormone treatment has no adverse effects on metabolic health profile. Thus, GH-treated young adults with PWS who have attained AH benefit from continuation of GH treatment without safety concerns regarding metabolic health.