A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results(792 views) Saccà F, Quarantelli M, Rinaldi C, Tucci T, Piro R, Perrotta G, Carotenuto B, Marsili A, Palma V, De Michele G, Brunetti A, Brescia Morra V, Filla A, Salvatore M
Keywords: Amyotrophic Lateral Sclerosis, Growth Hormone, Homa-Ir, Igf-I, Igfbp-3, Insulin, Arginine, Choline, Creatine, Gonadorelin, Human Growth Hormone, N Acetylaspartic Acid, Placebo, Riluzole, Somatomedin Binding Protein 3, Adult, Aged, Amyotrophic Lateral Sclerosis Functional Rating Scale Revised, Clinical Article, Controlled Study, Disease Course, Disease Duration, Disease Severity, Double Blind Procedure, Drug Dose Increase, Female, Glucose Blood Level, Growth Hormone Deficiency, Hormone Determination, Hypertension, Injection Site Reaction, Insulin Resistance, Joint Stiffness, Joint Swelling, Limb Weakness, Mortality, Motor Cortex, Motor Performance, Neuroimaging, Nuclear Magnetic Resonance Spectroscopy, Peripheral Edema, Phase 2 Clinical Trial, Priority Journal, Randomized Controlled Trial, Side Effect, 80 And Over, Double-Blind Method, Endpoint Determination, Image Processing, Computer-Assisted, Insulin-Like Growth Factor Binding Protein 3, Magnetic Resonance Imaging, Middle Aged, Neuroprotective Agents, Recombinant Proteins,
Affiliations: *** IBB - CNR ***
Department of Neurological Sciences, University Federico II, Via Pansini, 5, 80131 Naples, NA, Italy. francesco.sacca@unina.it
Biostructure and Bioimaging Institute, National Research Council, Naples, Italy
U.O.C. Neurofisiopatologia, PO S. Gennaro ASL Napoli 1, Naples, Italy
U. O. C. Neurofisiopatologia, PO S. Gennaro ASL Napoli 1, Naples, Italy
References: Bensimon, G., Lacomblez, L., Meininger, V., A controlled trial of riluzole in amyotrophic lateral sclerosis (1994) New England Journal of Medicine, 330 (9), pp. 585-591. , DOI 10.1056/NEJM19940303330090
Morselli, L.L., Bongioanni, P., Genovesi, M., Growth hormone secretion is impaired in amyotrophic lateral sclerosis (2006) Clin Endocrinol (Oxf), 65, pp. 385-388. , 10.1111/j.1365-2265.2006.02609.x 1:CAS:528:DC%2BD28XhtVOqtLjK
Lai, E.C., Felice, K.J., Festoff, B.W., Gawel, M.J., Gelinas, D.F., Kratz, R., Murphy, M.F., Rudnicki, S.A., Effect of recombinant human insulin-like growth factor-I on progression of ALS: A placebo-controlled study (1997) Neurology, 49 (6), pp. 1621-1630
Borasio, G.D., Robberecht, W., Leigh, P.N., Emile, J., Guiloff, R.J., Jerusalem, F., Silani, V., Dobbins, T., A placebo-controlled trial of insulin-like growth factor-I in amyotrophic lateral sclerosis (1998) Neurology, 51 (2), pp. 583-586
Sorenson, E.J., Windbank, A.J., Mandrekar, J.N., Subcutaneous IGF-1 is not beneficial in 2-year ALS trial (2008) Neurology, 71, pp. 1770-1775. , 19029516 10.1212/01.wnl.0000335970.78664.36 1:CAS:528:DC%2BD1cXhtlylurjK
Smith, R.A., Melmed, S., Sherman, B., Frane, J., Munsat, T.L., Festoff, B.W., Recombinant growth hormone treatment of amyotrophic lateral sclerosis (1993) Muscle and Nerve, 16 (6), pp. 624-633. , DOI 10.1002/mus.880160608
Cedarbaum, J.M., Stambler, N., Malta, E., Fuller, C., Hilt, D., Thurmond, B., Nakanishi, A., The ALSFRS-R: A revised ALS functional rating scale that incorporates assessments of respiratory function (1999) Journal of the Neurological Sciences, 169 (1-2), pp. 13-21. , DOI 10.1016/S0022-510X(99)00210-5, PII S0022510X99002105
Suhy, J., Miller, R.G., Rule, R., Schuff, N., Licht, J., Dronsky, V., Gelinas, D., Weiner, M.W., Early detection and longitudinal changes in amyotrophic lateral sclerosis by 1H MRSI (2002) Neurology, 58 (5), pp. 773-779
Matthews, D.R., Hosker, J.P., Rudenski, A.S., Homeostasis model assessment: Insulin resistance and β-cell function from fasting plasma glucose and insulin concentrations in man (1985) Diabetologia, 28 (7), pp. 412-419. , DOI 10.1007/BF00280883
Aberg, N.D., Lind, J., Isgaard, J., Georg Kuhn, H., Peripheral growth hormone induces cell proliferation in the intect adult rat brain (2010) Growth Horm IGF Res, 20, pp. 264-269. , 10.1016/j.ghir.2009.12.003
Kaspar, B.K., Frost, L.M., Christian, L., Umapathi, P., Gage, F.H., Synergy of insulin-like growth factor-1 and exercise in amyotrophic lateral sclerosis (2005) Annals of Neurology, 57 (5), pp. 649-655. , DOI 10.1002/ana.20451
Kaspar, B.K., Llado, J., Sherkat, N., Rothstein, J.D., Gage, F.H., Retrograde viral delivery of IGF-1 prolongs survival in a mouse ALS model (2003) Science, 301 (5634), pp. 839-842. , DOI 10.1126/science.1086137
Buckway, C.K., Guevara-Aguirre, J., Pratt, K.L., Burren, C.P., Rosenfeld, R.G., The IGF-I generation test revisited: A marker of GH sensitivity (2001) Journal of Clinical Endocrinology and Metabolism, 86 (11), pp. 5176-5183. , DOI 10.1210/jc.86.11.5176
Pellecchia, M.T., Pivonello, R., Monsurro, M.R., The GH-IGF system in amyotrophic lateral sclerosis: Correlations between pituitary GH secretion capacity, insulin-like growth factors and clinical features (2010) Eur J Neurol, 17, pp. 666-671. , 20002733 10.1111/j.1468-1331.2009.02896.x 1:STN:280: DC%2BC3czpsVKhsw%3D%3D
Salvatore, E., Rinaldi, C., Tucci, T., Growth hormone response to arginine test differentiates between two subgroups of Huntington's disease patients (2011) J Neurol Neurosurg Psychiatry, 82, pp. 543-547
Reyes, E.T., Perurena, O.H., Festoff, B.W., Insulin resistance in amyotrophic lateral sclerosis (1984) Journal of the Neurological Sciences, 63 (3), pp. 317-324. , DOI 10.1016/0022-510X(84)90154-0
Pradat, P.F., Bruneteau, G., Gordon, P.H., Impaired glucose tolerance in patients with amyotrophic lateral sclerosis (2010) Amyotroph Lateral Scler, 11, pp. 166-171. , 20184518 10.3109/17482960902822960 1:CAS:528:DC%2BC3cXisV2msbw%3D
Torres-Aleman, I., Barrios, V., Berciano, J., The peripheral insulin-like growth factor system in amyotrophic lateral sclerosis (1998) Neurology, 50, pp. 772-776. , 9521273 1:STN:280:DyaK1c7otVGluw%3D%3D
Corbo, M., Lunetta, C., Magni, P., Free insulin-like growth factor (IGF)-1 and IGF-binding proteins-2 and -3 in serum and cerebrospinal fluid of amyotrophic lateral sclerosis patients (2010) Eur J Neurol, 17, pp. 398-404. , 19845745 10.1111/j.1468-1331.2009.02815.x 1:STN:280: DC%2BC3czitlGquw%3D%3D
Hosback, S., Hardiman, O., Nolan, C.M., Doyle, M.A.C., Gorman, G., Lynch, C., O'Toole, O., Jakeman, P., Circulating insulin-like growth factors and related binding proteins are selectively altered in amyotrophic lateral sclerosis and multiple sclerosis (2007) Growth Hormone and IGF Research, 17 (6), pp. 472-479. , DOI 10.1016/j.ghir.2007.06.002, PII S109663740700086X
Olivecrona, H., Hilding, A., Ekstrom, C., Barle, H., Nyberg, B., Moller, C., Delhanty, P.J., Tally, M., Acute and short-term effects of growth hormone on insulin-like growth factors and their binding proteins: Serum levels and hepatic messenger ribonucleic acid responses in humans (1999) Journal of Clinical Endocrinology and Metabolism, 84 (2), pp. 553-560. , DOI 10.1210/jc.84.2.553
Butt, A.J., Firth, S.M., King, M.A., Baxter, R.C., Insulin-like growth factor-binding protein-3 modulates expression of Bax and Bcl-2 and potentiates p53-independent radiation-induced apoptosis in human breast cancer cells (2000) Journal of Biological Chemistry, 275 (50), pp. 39174-39181. , DOI 10.1074/jbc.M908888199
Liao, L., Dearth, R.K., Zhou, S., Britton, O.L., Lee, A.V., Xu, J., Liver-specific overexpression of the insulin-like growth factor-I enhances somatic growth and partially prevents the effects of growth hormone deficiency (2006) Endocrinology, 147 (8), pp. 3877-3888. , http://endo.endojournals.org/cgi/reprint/147/8/3877, DOI 10.1210/en.2005-1537
Niebroj-Dobosz, I., Janik, P., Soko-Çowska, B., Kwiecinski, H., Matrix metalloproteinases and their tissue inhibitors in serum and cerebrospinal fluid of patients with amyotrophic lateral sclerosis (2010) Eur J Neurol, 17, pp. 226-231. , 19796283 10.1111/j.1468-1331.2009.02775.x 1:STN:280: DC%2BC3czitlGjuw%3D%3D
Mitsui, Y., Mochizuki, S., Kodama, T., Shimoda, M., Ohtsuka, T., Shiomi, T., Chijiiwa, M., Okada, Y., ADAM28 is overexpressed in human breast carcinomas: Implications for carcinoma cell proliferation through cleavage of insulin-like growth factor binding protein-3 (2006) Cancer Research, 66 (20), pp. 9913-9920. , DOI 10.1158/0008-5472.CAN-06-0377
A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results