Background: Adults with growth hormone (GH) de®ciency (GHD) may experience physical and psychological disturbances, which can affect their quality of life (QOL). Objectives: To develop and validate a disease-speci®c module from the previously published QOL measure Questions on Life Satisfaction Modules (QLS M ): the QLS M -H that speci®cally addressed the needs of patients with hypopituitarism. A second aim was for the questionnaire to be applicable across different cultural backgrounds in order to evaluate the ef®cacy of therapy in large, international clinical trials, thus providing additional clinical endpoints for these studies. Design: A preliminary German language version of the QLS M -H was developed from 26 semistructured interviews of adults with GHD. The questionnaire was then independently translated into ®ve other languages and applied in open, non-controlled, multicentre, longitudinal studies to patient n 717 and normative populations n 2700X Methods: A revised, nine-item version of the questionnaire was developed, based on previously de®ned criteria, and was evaluated for reliability and validity. Sensitivity to detect changes after GH replacement was also assessed. Results: The 16 items of the preliminary questionnaire were reduced to nine items on the basis of the correlation of items/factors from initial patient interviews. Psychometric analysis revealed the reliability of the nine-item scale. The Cronbach's alpha scores ranged from 0.81 to 0.89 and the test± retest correlations ranged from 0.76 to 0.88, all of which indicate reliability over time. Mean scores increased signi®cantly during GH replacement therapy, with observed changes greater than those seen with the non-speci®c modules of the QLS M , indicating the sensitivity of the scale. Conclusions: The QLS M -H questionnaire is concise, easy to complete, and can be effectively applied across different cultural backgrounds. Psychometric evaluation of the questionnaire reveals that it is a valid, reliable and sensitive tool useful for assessing impaired life satisfaction in adult patients with GHD and also for monitoring the ef®cacy of GH therapy.
Weight loss, induced by increased energy expenditure and reduced energy intake, occurs regularly during prolonged exposure to altitude above 5000 m. Loss of fat accounts for up to 74% of this weight loss. 1 Furthermore, loss of appetite is one of the most frequent symptoms of acute mountain sickness (AMS). 2 As leptin is a key mediator in the neuroendocrine regulation of energy homeostasis and appetite, 3 we investigated the effect of hypobaric hypoxia at high altitude on serum leptin levels in men, using a highly sensitive and speci®c method for leptin quanti®cation. 4 Mean serum leptin levels in 20 male mountaineers after active ascent to 4559 m (age: 19 ± 42 y) increased from 1.22 AE 0.19 ngaml (120 m, all values mean AE s.e.m. 9:00 a.m.) to 2.06 AE 0.34 ngaml (mean pO 2 : 43.2 mmHg, 9:00 a.m., 22 h after ascent, P 0.0003). This effect was not reversible after 1 h of treatment with 33% oxygenenriched air and appeared to be more pronounced in subjects with loss of appetite (78% increase, n 11), than in those without loss of appetite (52% increase, n 9). Loss of appetite was documented by the Environmental Symptom Questionnaire. 1 However, physical strain during the active ascent and single measurements of leptin, which is secreted in a pulsatile manner by adipocytes were identi®ed as possible confounding factors in this study. Therefore, in a second study serum leptin levels were measured in 18 volunteers (age: 20 ± 41 y) at 490 m (after 1, 4, 12 and 20 h) and at 4559 m (1, 4, 12, 20 (and 32) h after transportation by helicopter). In individuals with loss of appetite mean serum leptin levels increased from 3.19 AE 0.89 ngaml (490 m, 6:00 a.m.) to 4.89 AE 1.18 ngaml (4559 m, 6:00 a.m., P 0.02, n 12), but no signi®cant increase was found in individuals without loss of appetite (2.17 ngaml vs 2.55 ngaml, n 6, 6:00 a.m., P 0.35). An increase in integrated serum leptin levels (mean area under the curve) from 53.8 AE 13.8 ngaml h to 66.3 AE 16.2 ngaml h was found in individuals with loss of appetite (1 ± 20 h, P 0.008), but not in volunteers without loss of appetite (38.7 AE 6.4 ngaml h (490 m), 6.00 a.m. 40.8AE 13.2 ngaml h (4559 m, P 0.35). As loss of appetite is a frequent symptom of AMS 2 it is not surprising that at 4559 m a signi®cant increase in serum leptin levels was also found in those volunteers with AMS, compared to levels at 490 m. AMS was de®ned as a functional Lake Louise Score b1 (n 10, P 0.028). 5 Statistics were performed by non-parametric testing (Mann ± Whitney test and Wilcoxon test). Effects due to change in plasma volume have been excluded. Individuals with loss of appetite showed a tendency to higher leptin levels baseline than those without loss of appetite (P 0.1), but mean body mass indices were not signi®cantly different between the analysed subgroups. In summary, in two independent studies, elevated leptin levels at high altitude were demonstrated, and found to be associated with loss of appetite. Thus, leptin may be a player in the altered neuroendocrine regulation of energy homeostasis...
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