This cross-sectional observational study included 71 children and adolescents with isolated idiopathic GHD [female, n=17 (24%), mean age 13.7±2.6 years] who were consulted and treated at İstanbul University, İstanbul Faculty of Medicine, Department of Pediatric Endocrinology (28 (link)). GHD was identified using clinical, auxological and biochemical criteria from the GH Research Society. The inclusion criteria were: (i) GHD, defined as an absence of GH (peak GH levels below 10 µg/L) in response to two stimuli (clonidine and L-Dopa test); and (ii) treatment with rhGH for at least one year. The exclusion criteria were: (i) multiple pituitary hormone deficiency, except for hypothyroidism; (ii) any cardiovascular, respiratory, renal, or liver diseases; (iii) personal or family history of lipid disorders; and (iv) bioinactive GH syndrome. All children with GHD were treated with biosynthetic rhGH once daily before bedtime, for a total of seven injections per week. The initial subcutaneous dose was 30.2±4.1 mcg/kg/day which was gradually adjusted during follow-up based on growth velocity and IGF-1 concentration. The demographic, clinical, and radiologic information, including magnetic resonance imaging (MRI) findings, were obtained from the patient records.
The control group included 44 healthy, age- and sex-matched children [female, n=15 (34.1%), mean age 13.4±2.9 years]. Organic diseases were excluded, based on physical examination in our hospital. The control group was selected from children referred to our hospital for well-child care visits.
The procedure was performed with the written and informed consent of the parents or guardians of the minors and in accordance with all applicable ethical and legal rules for medical research involving human subjects, according to the Declaration of Helsinki ethical statement. The study protocol and this consent procedure were approved by the İstanbul University, İstanbul Faculty of Medicine Local Ethics Committee (date: 20.06.2014, no: 2014/990).