A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results (1219 views)
J Neurol (ISSN: 1432-1459, 0340-5354, 1432-1459electronic), 2012 Jan; 259(1): 132-138.
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Paper type: Journal Article, Clinical Trial, Phase Ii, Randomized Controlled Trial, Research Support, Non-U. S. Gov'T
Impact factor: 3.578, 5-year impact factor: 3.598
Url: http://www.scopus.com/inward/record.url?eid=2-s2.0-84856701376&partnerID=40&md5=9adf7ccdcb1d74076ea7dad4ceb8723a
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, Amyotrophic Lateral Sclerosis Drug Therapy Metabolism Pathology , Choline Blood , Creatine Blood , Hormones Blood , Human Growth Hormone Blood Therapeutic Use , Insulin-Like Growth Factor Binding Protein 3 Blood , Insulin-Like Growth Factor I Analysis , Motor Cortex Pathology , Neuroprotective Agents Therapeutic Use , Recombinant Proteins Therapeutic Use , Riluzole Therapeutic Use
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:
Not available.
J Neurol (ISSN: 1432-1459, 0340-5354, 1432-1459electronic), 2012 Jan; 259(1): 132-138.
Export to BibTeX Export to EndNote
Paper type: Journal Article, Clinical Trial, Phase Ii, Randomized Controlled Trial, Research Support, Non-U. S. Gov'T
Impact factor: 3.578, 5-year impact factor: 3.598
Url: http://www.scopus.com/inward/record.url?eid=2-s2.0-84856701376&partnerID=40&md5=9adf7ccdcb1d74076ea7dad4ceb8723a
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, Amyotrophic Lateral Sclerosis Drug Therapy Metabolism Pathology , Choline Blood , Creatine Blood , Hormones Blood , Human Growth Hormone Blood Therapeutic Use , Insulin-Like Growth Factor Binding Protein 3 Blood , Insulin-Like Growth Factor I Analysis , Motor Cortex Pathology , Neuroprotective Agents Therapeutic Use , Recombinant Proteins Therapeutic Use , Riluzole Therapeutic Use
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:
Not available.
A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results
Amyotrophic lateral sclerosis (ALS) is a fatal neurological disease with motor neuron degeneration. Riluzole is the only available treatment. Two-thirds of ALS patients present with growth hormone (GH) deficiency. The aim of this study is to determine if add-on of GH to riluzole, with an individually regulated dose based on Insulin-like growth factor 1 (IGF-I) production, was able to reduce neuronal loss in the motor cortex, reduce mortality, and improve motor function of ALS patients. Patients with definite/probable ALS, in treatment with riluzole, aged 40-85 years, and with disease duration ≥3 years were enrolled. The study was randomized, placebo controlled, and double blind. Before treatment, patients were tested with a GH releasing hormone (GHRH) + arginine test. The initial dose of GH was 2 IU s.c. every other day, and was progressively increased to a maximum of 8 IU. Primary endpoint was N-acetylaspartate/(creatine + choline) (NAA/Cre + Cho) ratio in motor cortex assessed by magnetic resonance spectroscopy performed at months 0, 6, and 12. Secondary endpoints were mortality and ALS functional rating scale revised (ALSFRS-R). The NAA/(Cre + Cho) ratio decreased in all patients who completed the trial. No significant difference was noted between treated and placebo group. At baseline, although IGF-I levels were within the normal range, 73% of patients had GH deficiency, being severe in half of them. Compared with bulbar onset, spinal-onset patients showed more depressed GH response to the GHRH + arginine stimulation test (10.4 ± 7.0 versus 15.5 ± 8.1 ng/mL; p < 0.05). Insulin resistance [homeostasis model assessment of insulin resistance (HOMA-IR)] increased from 2.1 ± 1.0 at baseline to 4.6 ± 1.9 at 12 months (p < 0.001). Insulin-like growth factor (IGF) binding protein 3 (IGFBP-3) decreased from 8,435 ± 4,477 ng/mL at baseline to 3,250 ± 1,780 ng/mL at 12 months (p < 0.001). The results show that GH exerted no effect on cerebral NAA or clinical progression assessed by ALSFRS-R. Two-thirds of ALS patients had GH deficit, with higher levels in the bulbar-onset group. During follow-up, patients showed progressive increase in HOMA-IR and decrease in IGFBP-3 levels. © 2011 Springer-Verlag.
Amyotrophic lateral sclerosis (ALS) is a fatal neurological disease with motor neuron degeneration. Riluzole is the only available treatment. Two-thirds of ALS patients present with growth hormone (GH) deficiency. The aim of this study is to determine if add-on of GH to riluzole, with an individually regulated dose based on Insulin-like growth factor 1 (IGF-I) production, was able to reduce neuronal loss in the motor cortex, reduce mortality, and improve motor function of ALS patients. Patients with definite/probable ALS, in treatment with riluzole, aged 40-85 years, and with disease duration ≥3 years were enrolled. The study was randomized, placebo controlled, and double blind. Before treatment, patients were tested with a GH releasing hormone (GHRH) + arginine test. The initial dose of GH was 2 IU s.c. every other day, and was progressively increased to a maximum of 8 IU. Primary endpoint was N-acetylaspartate/(creatine + choline) (NAA/Cre + Cho) ratio in motor cortex assessed by magnetic resonance spectroscopy performed at months 0, 6, and 12. Secondary endpoints were mortality and ALS functional rating scale revised (ALSFRS-R). The NAA/(Cre + Cho) ratio decreased in all patients who completed the trial. No significant difference was noted between treated and placebo group. At baseline, although IGF-I levels were within the normal range, 73% of patients had GH deficiency, being severe in half of them. Compared with bulbar onset, spinal-onset patients showed more depressed GH response to the GHRH + arginine stimulation test (10.4 ± 7.0 versus 15.5 ± 8.1 ng/mL; p < 0.05). Insulin resistance [homeostasis model assessment of insulin resistance (HOMA-IR)] increased from 2.1 ± 1.0 at baseline to 4.6 ± 1.9 at 12 months (p < 0.001). Insulin-like growth factor (IGF) binding protein 3 (IGFBP-3) decreased from 8,435 ± 4,477 ng/mL at baseline to 3,250 ± 1,780 ng/mL at 12 months (p < 0.001). The results show that GH exerted no effect on cerebral NAA or clinical progression assessed by ALSFRS-R. Two-thirds of ALS patients had GH deficit, with higher levels in the bulbar-onset group. During follow-up, patients showed progressive increase in HOMA-IR and decrease in IGFBP-3 levels. © 2011 Springer-Verlag.
A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results
| ▼ Characterization of neurotoxic and neuroprotective factors by using computational methodologies |
A randomized controlled clinical trial of growth hormone in amyotrophic lateral sclerosis: clinical, neuroimaging, and hormonal results
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Lanzillo R, Di Somma C, Quarantelli M, Ventrella G, Vacca G, Liuzzi R, Amato L, Orefice G, Colao A, Brescia Morra V
* Growth Hormone Axis In Early Multiple Sclerosis Patients Before And After 2 Years Treatment With Interferon Beta-1b - An Interim Analysis (621 views)
Proceedings Of The Xlii Meeting Of The Italian Society Of Neurology, 2011; nd: 360-360.
Impact Factor: 0
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De Leva MF, Filla A, Criscuolo C, Tessa A, Pappata S, Quarantelli M, Bilo L, Peluso S, Antenora A, Longo DL, Santorelli FM, De Michele G
* Complex phenotype in an Italian family with a novel mutation in SPG3A (1276 views)
J Neurol (ISSN: 0340-5354, 1432-1459, 1432-1459electronic), 2010 Mar; 257(3): 328-331.
Impact Factor: 3.853
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Milardi D, Pappalardo M, Grasso DM, La Rosa C
* Unveiling the unfolding pathway of FALS associated G37R SOD1 mutant: A computational study (716 views)
Mol Biosyst (ISSN: 1742-206x), 2010; 6(6): 1032-1039.
Impact Factor: 3.825
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Cittadini A, Saldamarco L, Marra AM, Arcopinto M, Carlomagno G, Imbriaco M, Del Forno D, Vigorito C, Merola B, Oliviero U, Fazio S, Sacca L
* Growth Hormone Deficiency in Patients with Chronic Heart Failure and Beneficial Effects of Its Correction (1201 views)
Journal Of Clinical Endocrinology & Metabolism (ISSN: 0021-972x), 2009 Sep; 94(9): 3329-3336.
Impact Factor: 6.202
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Sacca F, Quarantelli M, Rinaldi C, Tucci T, Piro R, Carotenuto B, Marsili A, Palma V, Bresciamorra V, Brunetti A, De Michele G, Filla A, Salvatore M
* A Double-Blind, Placebo-Controlled, Randomized Trial of Growth Hormone as Add-On Therapy to Riluzole in Patients with Amyotrophic Lateral Sclerosis: Preliminary MRS, Hormonal, and Population Analysis (782 views)
Neurology (ISSN: 0028-3878, 1526-632x, 1526-632xelectronic), 2009 Mar 17; 72(11): N/D-N/D.
Impact Factor: 8.172
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Sacca F, Quarantelli M, Rinaldi C, Tucci T, Piro R, Carotenuto B, Marsili A, Palma V, Bresciamorra V, Brunetti A, De Michele G, Filla A, Salvatore M
* A Randomized Trial of Growth Hormone as Add. On Therapy to Riluzole in Patients with Amyotrophic Lateral Sclerosis (828 views)
Neurology (ISSN: 0028-3878, 1526-632x, 1526-632xelectronic), 2009 Mar 17; 76(9): N/D-N/D.
Impact Factor: 8.172
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Colao A, Di Somma C, Cuocolo A, Spinelli L, Acampa W, Spiezia S, Rota F, Savanelli MC, Lombardi G
* Does a gender-related effect of growth hormone (GH) replacement exist on cardiovascular risk factors, cardiac morphology, and performance and atherosclerosis? Results of a two-year open, prospective study in young adult men and women with severe GH deficiency (706 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2005 Sep; 90(9): 5146-5155.
Impact Factor: 6.02
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Colao A, Di Somma C, Cuocolo A, Filippella M, Rota F, Acampa W, Savastano S, Salvatore M, Lombardi G
* The severity of growth hormone deficiency correlates with the severity of cardiac impairment in 100 adult patients with hypopituitarism: An observational, case-control study (781 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2004 Dec; 89(12): 5998-6004.
Impact Factor: 5.778
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Spinelli L, Petretta M, Verderame G, Carbone G, Venetucci AA, Petretta A, Acampa W, Bonaduce D, Colao A, Cuocolo A
* Left ventricular diastolic function and cardiac performance during exercise in patients with acromegaly (864 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2003 Sep; 88(9): 4105-4109.
Impact Factor: 5.873
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Colao A, Marzullo P, Cuocolo A, Spinelli L, Pivonello R, Bonaduce D, Salvatore M, Lombardi G
* Reversal of acromegalic cardiomyopathy in young but not in middle-aged patients after 12 months of treatment with the depot long-acting somatostatin analogue octreotide (1296 views)
Clin Endocrinol (ISSN: 0300-0664, 1365-2265, 1365-2265electronic), 2003 Feb; 58(2): 169-176.
Impact Factor: 2.767
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Colao A, Spinelli L, Cuocolo A, Spiezia S, Pivonello R, Di Somma C, Bonaduce D, Salvatore M, Lombardi G
* Cardiovascular consequences of early-onset growth hormone excess (1047 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2002 Jul; 87(7): 3097-3104.
Impact Factor: 5.199
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Colao A, Di Somma C, Pivonello R, Cuocolo A, Spinelli L, Bonaduce D, Salvatore M, Lombardi G
* The cardiovascular risk of adult GH deficiency (GHD) improved after GH replacement and worsened in untreated GHD: A 12-month prospective study (762 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2002 Mar; 87(3): 1088-1093.
Impact Factor: 5.199
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Colao A, Di Somma C, Cuocolo A, Spinelli L, Tedesco N, Pivonello R, Bonaduce D, Salvatore M, Lombardi G
* Improved cardiovascular risk factors and cardiac performance after 12 months of growth hormone (GH) replacement in young adult patients, with GH deficiency (1017 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2001 May; 86(5): 1874-1881.
Impact Factor: 5.16
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Colao A, Cuocolo A, Marzullo P, Nicolai E, Ferone D, Morte A, Pivonello R, Salvatore M, Lombardi G
* Is the acromegalic cardiomyopathy reversible? Effect of 5-year normalization of growth hormone and insulin-like growth factor I levels on cardiac performance (760 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2001 Apr; 86(4): 1551-1557.
Impact Factor: 5.16
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Colao A, Marzullo P, Ferone D, Spinelli L, Cuocolo A, Bonaduce D, Salvatore M, Boerlin V, Lancranjan I, Lombardi G
Cardiovascular effects of depot long-acting somatostatin analog sandostatin LAR in acromegaly (718 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2000 Sep; 85(9): 3132-3140.
Impact Factor: 5.447
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Marzullo P, Cuocolo A, Ferone D, Pivonello R, Salvatore M, Lombardi G, Colao A
Cardiac effect of thyrotoxicosis in acromegaly (854 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 2000 Apr; 85(4): 1426-1432.
Impact Factor: 5.447
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Colao A, Cuocolo A, Di Somma C, Cerbone G, Della Morte A, Pivonello R, Nicolai E, Salvatore M, Lombardi G
Does the age of onset of growth hormone deficiency affect cardiac performance? A radionuclide angiography study (950 views)
Clin Endocrinol (ISSN: 0300-0664, 1365-2265, 1365-2265electronic), 2000 Apr; 52(4): 447-455.
Impact Factor: 2.922
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Colao A, Cuocolo A, Di Somma C, Cerbone G, Della Morte A, Nicolai E, Lucci R, Salvatore M, Lombardi G
Impaired cardiac performance in elderly patients with growth hormone deficiency (778 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1999 Nov; 84(11): 3950-3955.
Impact Factor: 5.805
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Colao A, Cuocolo A, Marzullo P, Nicolai E, Ferone D, Della Morte A, Petretta M, Salvatore M, Lombardi G
Impact of patient's age and disease duration on cardiac performance in acromegaly: A radionuclide angiography study (598 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1999 May; 84(5): 1518-1523.
Impact Factor: 5.805
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Colao A, Lastoria S, Ferone D, Varrella P, Marzullo P, Pivonello R, Cerbone G, Acampa W, Salvatore M, Lombardi G
The pituitary uptake of In-111-DTPA-D-Phe(1)-octreotide in the normal pituitary and in pituitary adenomas (755 views)
J Endocrinol Invest (ISSN: 0391-4097, 1720-8386electronic), 1999 Mar; 22(3): 176-183.
Impact Factor: 0.957
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Colao A, Cuocolo A, Marzullo P, Nicolai E, Ferone D, Florimonte L, Salvatore M, Lombardi G
Effects of 1-year treatment with octreotide on cardiac performance in patients with acromegaly (984 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1999 Jan; 84(1): 17-23.
Impact Factor: 5.805
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Longobardi S, Cuocolo A, Merola B, Di Rella F, Colao A, Nicolai E, Cardei S, Salvatore M, Lombardi G
Left ventricular function in young adults with childhood and adulthood onset growth hormone deficiency (1245 views)
Clin Endocrinol (ISSN: 0300-0664, 1365-2265, 1365-2265electronic), 1998 Feb; 48(2): 137-143.
Impact Factor: 3.101
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Ferone D, Lastoria S, Colao A, Varrella P, Cerbone G, Acampa W, Merola B, Salvatore M, Lombardi G
Correlation of scintigraphic results using 123I-methoxybenzamide with hormone levels and tumor size response to quinagolide in patients with pituitary adenomas (794 views)
J Clin Endocrinol Metab (ISSN: 0021-972x), 1998 Jan; 83(1): 248-252.
Impact Factor: 5.641
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Lombardi G, Colao A, Cuocolo A, Longobardi S, Di Somma C, Orio F, Merola B, Nicolai E, Salvatore M
Cardiological aspects of growth hormone and insulin-like growth factor- (1971 views)
J Pediatr Endocrinol Metab (ISSN: 0334-018x), 1997 Nov; 10(6): 553-560.
Impact Factor: 0.481
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Sijens PE, Knopp MV, Brunetti A, Wicklow K, Alfano B, Bachert P, Sanders JA, Stillman AE, Kett H, Sauter R
1H MR spectroscopy in patients with metastatic brain tumors: A multicenter study (672 views)
Magn Reson Med (ISSN: 0740-3194, 1522-2594electronic, 0740-3194linking), 1995 Jun; 33(6): 818-826.
Impact Factor: 3.012
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34 Records (30 excluding Abstracts).
Total impact factor: 160.894 (144.55 excluding Abstracts).
Total 5 year impact factor: 125.674 (111.276 excluding Abstracts).
Total impact factor: 160.894 (144.55 excluding Abstracts).
Total 5 year impact factor: 125.674 (111.276 excluding Abstracts).
1219 views. Last view on Sunday 18 May 2025, 10:53:29
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