Metabolic effects of 20 kilodalton human growth hormone (20K-hGH) for adults with growth hormone deficiency: results of an exploratory uncontrolled multicenter clinical trial of 20K-hGH.

Hayakawa M - J Clin Endocrinol Metab - 01-APR-2004; 89(4): 1562-71
NLM Citation ID:
15070913 (PubMed)
Full Source Title:
Journal of Clinical Endocrinology and Metabolism
Publication Type:
Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial
Author Affiliation:
Research and Development Operations, Nihon Schering K.K., Osaka 532-0004, Japan.
Hayakawa M; Shimazaki Y; Tsushima T; Kato Y; Takano K; Chihara K; Shimatsu A; Irie M
The biological effects of 20-kDa human HGH (20K-hGH), which is produced in the pituitary by alternative splicing of GH mRNA and comprises approximately 6% of all GH in serum, have not been reported. We have investigated the metabolic effects of recombinant 20K-hGH in adult patients with HGH deficiency in an exploratory study. Three doses of 20K-hGH (0.006, 0.012, and 0.024 mg/kg.d), were administered for 16 wk to three groups (consisting of 18 or 19 subjects), respectively. The 20K-hGH dose-dependently increased serum IGF-I and IGFBP-3 levels, and the lowest dose (0.006 mg/kg) was enough to normalize both hormones by wk 4. Serum osteocalcin levels and urinary deoxypyridinoline excretion were also dose-dependently increased. There was a significant decrease in body fat mass with an increase of lean body mass at the lowest dose of 0.006 mg/kg.d. Blood glucose and serum insulin were increased significantly at 4 wk only in the high-dose group (0.024 mg/kg). Glucose tolerance was slightly impaired in 26-39% of patients in all treatment groups as judged by oral glucose tolerance tests, but there was no development of overt diabetes. The major adverse event in the 20K-hGH treatment was peripheral edema, similar to the incidence reported for 22K-hGH. The data demonstrated that 20K-hGH had metabolic effects comparable to those of 22K-hGH in humans. The results suggest that 20K-hGH could be used to treat GH-deficient patients, although further studies may be required to investigate the optimum dose and superiority of 20K-hGH over 22K-hGH in a comparative study.
Major Subjects:

Additional Subjects:

Chemical Compound Name:
(Insulin-Like Growth Factor Binding Protein 3); (Lipids); (Recombinant Proteins); 12629-01-5(Human Growth Hormone); 50-99-7(Glucose); 67763-96-6(Insulin-Like Growth Factor I)

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