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Growth Hormone Treatment in Adults

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Growth Hormone Treatment in Adults GROWTH HORMONE TREATMENT IN ADULTS Groeihormoon behandeling bij volwassenen PROEFSCHRIFT TER VERKRIJGING VAN DE GRAAD VAN DOCTOR AAN DE ERASMUS UNIVERSITEIT ROTTERDAM OP GEZAG VAN DE RECTOR MAGNIFICUS PROF. DR. C.J. RIJNVOS EN VOLGENS BESLUIT VAN HET COLLEGE VAN DEKANEN. DE OPENBARE VERDEDJGING ZAL PLAATSVINDEN OP WOENSDAG 13 MEl 1992 OM 13.45 UUR. door ARJEN BINNERTS Geboren te Dordrecht PROMOTIE COMMISSIE Promotor: Prof. Dr. S.W.J. Lamberts Overige leden: Prof. Dr. J.C. Birkenhager Prof. Dr. W.C. Hulsmann Prof. Dr. H.K.A. Visser The support by Eli Lilly Nederland BV for the studies described in this thesis is gratefully acknowledged. "YGedrukt door: Drukkerij Haveka B.V., Alblasserdam aan mijn ouders CONTENTS List of abbreviations 6 Chapter 1 Introduction 1.1. General introduction 9 1.2. Physiology of growth hormone secretion and assessment of GH deficiency 12 1.3. Growth hormone functions 1.3.1. Incidence of GH deficiency in adulthood 17 1.3.2. GH and subjective well being 17 1.3.3. GH and body composition, muscle mass, and strength 18 1.3.4. GH and bone homeostasis 19 1.3.5. GH and carbohydrate and lipid homeostasis 22 1.3.6. GH and other hormonal function 23 1.3.7. GH and the cardiovascular system 25 1.3.8. GH and immune function 28 1.4. Growth hormone as an adjunct to the nutritional treatment of catabolic diseases 43 1.5. Growth hormone and cancer 50 1.6. Methods of body composition assessment 55 1. 7. Scope of the thesis 58 Chapter 2 Optimal GH dosage in the treatment of catabolic elderly adults 2.1. The effects of human growth hormone administration 59 in elderly adults with recent weight loss 2.2. Growth hormone administration in adults: minimal dose to induce nitrogen retention. 71 Chapter 3 The effect of human growth hormone administration on tumor growth, body weight and circulating insulin-like growth factor I levels of rats bearing a transplantable rat pituitary tumor (7315b). 81 4 Chapter 4 Body composition in GH deficient adults. 95 Chapter 5 The effect of GH administration in GH-deficient adults on bone, protein, carbohydrate and lipid homeostasis, as well as on body composition. 111 Chapter 6 Discussion 133 Summary 136 Samenvatting 138 Nawoord 140 Curriculum vitae 141 5 LIST OF ABBREVIATIONS ANOVA analysis of variance ANP atrial natriuretic peptide BCM body cell mass BIA body impedance analysis BMI body mass index BW body weight D,O deuteriumoxide DPA dual photon absorptiometry ECW extra-cellular water FFA free fatty acids FFM fat-free mass FM fat mass FSH follicular stimulating hormone FT4 free thyroxine GFR glomerular filtration rate GH growth hormone GHRH growth hormone-releasing hormone HBSA Hank's balanced salt solution HDL high density lipoprotein HSA human serum albumin HTL hepatic triglyceride lipase ICW intra-cellular water 6 IMP impedance IGF-1 insulin-like growth factor-1 LBM lean body mass LPL lipoprotein-lipase MEM minimal essential medium Prl prolactine PTH parathormone RIA radioimmunoassay RPF renal plasma flow rT3 reversed triiodothyronine SEM standard error of the mean SM-C somatomedin-C, now called: IGF-1 SMS somatostatin SPA single photon absorptiometry T3 triiodothyronine T4 thyroxine TBW total body water TG triglycerides TmP/GFR maximal renal tubular reabsorption of phosphorus corrected for the GFR TT4 total thyroxine u unit 7 CHAPTER 1 1.1.11\iTRODUCTION Growth promoting effects of crude anterior pituitary extracts in hypophysectomized and intact laboratory animals were first demonstrated in 1921 by Evans and Long (1). Following further isolation the diverse physiologic effects of a relative pure growth promoting factor in animals were described by Li et al in 1949 (2). After demonstration of a species specificity among growth hormones (GH) (3,4,5,6) and the development of a new procedure for crystallizing GH, enabling more GH with an increased purity to be obtained from human pituitaries (7), Beck et al (8) were the first to report the effects of human and monkey growth hormone in man. Subsequently many other reports appeared investigating the effects of the administration of pituitary- derived primate GH, for 1 week to 6 months, in adults with GH deficiency, in patients with a variety of other diseases and in normals (9, 10,11, 12). These effects included increased nitrogen, phosphorus, potassium and sodium retention, increased calcium absorption, hypercalciuria and disturbances in carbohydrate metabolism. Effects of GH administration in patients with burns (13,14,15) or trauma (16) were also investigated and showed promising results as to the reversal of catabolism/induction of anabolism. Raben was the first to report the successful stimulation of growth with human GH in a child with GH deficiency (17), and this was followed by many other reports (reviewed in ref 18). Due to the species specificity, requiring GH to be derived from the limited supply of primate (human) pituitaries obtained at autopsy, GH remained scarce. Its therapeutic use remained, under strict medical supervision by paediatric endocrinologists, limited to the treatment of children with dwarfism due to GH deficiency. Even in these children GH was administered in regimens now known to be insufficient for optimal growth, however. In 1985 the use of human pituitary-derived GH had to be stopped completely after reports of contamination of batches of GH by one or more pituitaries containing a "slow virus" causing Creutzfeldt-Jacob disease and resulting in several deaths (19,20,21 ,22,23,24). Following the development of recombinant DNA technology several pharmaceutical companies developed the ability to produce in limitless quantities human GH in vitro by Escherichiae Coli. Since 1986 Humatrope, bioequivalent and identical to human GH, manufactured by Eli Lilly & Co (Indianapolis, USA) is available for the treatment of children with short stature and research in adults (25). Other pharmaceutical industries also producing human GH are Novo Nordisk (Norditropin), KabNitrum 9 (Genotropin) and Genentech (Protropin). The studies described in this thesis have all been performed with Humatrop, provided for free by Eli Lilly Nederland. REFERENCES 1. Evans HM, Long JA. The effects of seeding the anterior lobe of the hypophysis on the oestrous cycle of the rat. Anat Rec 1921 ;21 :62-3. 2. U CH, Simpson ME, Evans HM. Influence of growth and adreno--corticotropic hormones on the body composition of hypophysectomized rats. Endocrinology 1949;44:71·5. 3. Mitchell ML, GuH!emin R, Selye H. The effect of somatotrophic hormone on the growth of normal and hypophysectomized guinea pigs. Endocrinology 1954;54:111-4. 4. Knobil E, Morse A, Greep RO. The effects of beef and monkey pituitary growth hormone on the costochondral junction in the hypophysectomized Rhesus monkey. Anat Rec 1956;124:320. 5. Raben MS. Westermeyer VW, leaf A. Metabolic effects of a new growth hormone preparation. J Clin Invest 1952;31:655. 6. Knobil E, Greep RO. The physiology of growth hormone with particular reference to its action in the rhesus monkey and the "species specificity" problem. Recent Prog Horm Res 1959;15:1- 58. 7. Raben MS. Preparation of growth hormone from pituitaries of man and monkey. Science 1957;125:883-4. 8. Beck JC, McGarry EE, Oyrenfurth I, Venning EH. The metabolic effects of human and monkey growth hormone in man. Science 1957;125:884-5. 9. Beck JC, McGarry EE, Dyrenfurth I, Venning EH. The metabolic effects of human and monkey growth hormone in man. Ann lnt Med 1958;49:1090-1105. 10. Henneman PH, Forbes AP, Moldawer M, Dempsey EF, carroll EL Effects of human growth hormone in man. J Clin Invest 1960;23:1223--38. 11. Beck JC, McGarry EE, Oyrenfurth I, Morgen RO, Bird ED, Venning EH. Primate growth hormone studies in man. Metabolism 1960;9:699-737. 12. Bergenstal OM, Lipsett MB. Metabolic effects of human growth hormone and growth hormone of other species in man. J Clin Endocrine! Metab 1960;20:1427-36. 13. Liljedahl SO, Gemzell CA. Plantin LO, Birke G. Effect of human growth hormone in patients with burns. Acta Chir Scand 1961 ;122:1-14. 14. Soroff HS, Rozin R. Mooty J, Lister J, Raben MS, Macaulay AJ, Paddock J. Role of human growth hormone ln the response to trauma: I. Metabolic effects following bums. Ann Surg 1967;166;739·52. 10 15. Wilmore OW, Moylan JA, Bristow SF, Mason AD, Pruitt BA. Anabolic effects of human growth hormone and high caloric feedings fo!!owing thermal injury. Surg Gynecol Obstet 1974;138:875- 84. 16. Johnston IDA, Hadden DR. Effect of human growth hormone on the metabolic response to surgical trauma. lancet 1963 i;584-6. 17. Raben MS. Treatment of a pituitary dwarf with human growth hormone. J Clin Endocrinol 1958;18:901-3. 18. Frasier SO. Human pituitary growth hormone (hGH) therapy in growth hormone deficiency. Endocr Rev 1983;4:155-70. 19. Anonymous. Ban on growth hormone. Lancet 1985;i:1172. 20. laron Z. Josefsberg Z. Withdrawal of human pituitary growth hormone. lancet 1985;1:1324. 21. Poweli.Jackson J, Weller RO, Kennedy P, Preece MA, Whitcombe EM, Newsom-Davis J. Creutzfeldt-Jacob disease after administration of human growth hormone. lancet 1985;ii:24443. 22. Brown P, Gajdusek DC, Gibbs CJ, Asher OM. Potential epidemic of Creutzfeldt-Jacob disease from human growth hormone therapy. N Engl J Med 1985;313:728-31. 23. UndeiWood LE, Fisher DA, Frasier SD, Gertner JM, Kaplan SL, Kirkland RT, Uppe BM, Raiti S. Degenerative neurologic disease in patients formerly treated with human growth hormone. J Pediatr 1985;107:10-2. 24. Brown P. Human growth hormone therapy and Creutzfeldt..Jacob disease: A drama in three acts. Pediatrics 1988;81 :85-92. 25. Eli U!ly Nederland. Humatrop.
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