Serum profiles and short-term metabolic effect of pituitary and authentic biosynthetic human growth hormone in man

Abstract. In a double-blind cross-over study we compared pituitary and methionine-free biosynthetic human growth hormone (P-hGH and B-hGH) with respect to pharmacokinetics and short-term metabolic effects in 9 hypopituitary children. They treated themselves for 4 weeks with 2 IU sc daily at 20.00 h. After admittance to hospital 2 IU was given: im the first day, and sc the second. They then switched over to the alternative preparation. The serum profiles of B- and P-hGH were identical. Comparing im and sc adsorption, the latter was slower and resulted in smaller areas under the curves, indicating greater local degradation. Both preparations caused identical increases in somatomedin-C, but slightly more sustained after sc injection. Plasma glucose, plasma glucagon, and serum insulin fluctuated within normal ranges. The glucose profile pointed at a modest anti-insulin effect of hGH when given in the morning. The concentration in the blood of lactate, alanine, glycerol and B-OH-butyrate, and in serum of triglyceride, cholesterol and carbamide revealed no abnormalities with either hGH preparation. Finally, no development of anti-GH or E. coli polypeptide antibodies was seen. In conclusion, the pharmacokinetics and short-term metabolic effects of B-hGH and P-hGH were identical.

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PHARMACOKINETICS AND SHORT TERM METABOLIC EFFECTS OF PITUITARY AND BIOSYNTHETIC HUMAN GROWTH HORMONE IN GH-DEFICIENT MAN. A DOUBLE-BLIND CROSSOVER STUDY

Pediatric Research ◽

10.1203/00006450-198801000-00077 ◽

1988 ◽

Vol 23 (1) ◽

pp. 114-114

Author(s):

Js Christiansen ◽

Jol Jørgensen ◽

A Flyvbjerg ◽

H Orskov ◽

N Skakkebak

Keyword(s):

Growth Hormone ◽

Crossover Study ◽

Human Growth Hormone ◽

Human Growth ◽

Metabolic Effects ◽

Short Term ◽

Double Blind ◽

Blind Crossover Study ◽

Double Blind Crossover Study

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Pharmacokinetics and Short-Term Metabolic Effects of Mammalian Cell-Derived Biosynthetic Human Growth Hormone in Man

Hormone Research ◽

10.1159/000182369 ◽

1992 ◽

Vol 37 (2) ◽

pp. 5-13 ◽

Cited By ~ 8

Author(s):

H.J. Zeisel ◽

W.v. Petrykowski ◽

U. Wais

Keyword(s):

Growth Hormone ◽

Mammalian Cell ◽

Human Growth Hormone ◽

Human Growth ◽

Metabolic Effects ◽

Short Term

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Low-Dose Amino Asid Supplementation: No Effects on Serum Human Growth Hormone and Insulin in Male Weightlifters

International Journal of Sport Nutrition ◽

10.1123/ijsn.3.3.290 ◽

1993 ◽

Vol 3 (3) ◽

pp. 290-297 ◽

Cited By ~ 31

Author(s):

G. Mikael Fogelholm ◽

Hannu K. Näveri ◽

Kai T.K. Kiilavuori ◽

Matti H.A. HärkÖnen

Keyword(s):

Growth Hormone ◽

Amino Acid ◽

Human Growth Hormone ◽

Treatment Time ◽

Serum Insulin ◽

Human Growth ◽

Amino Acid Supplementation ◽

Double Blind ◽

Acid Supplementation ◽

Time Interaction

Using a double-blind, crossover protocol, we studied the possible effects of a 4-day combined L-arginine, L-ornithine, and L-lysine supplementation (each 2 g/day, divided into two daily doses) on 24-hr level of serum human growth hormone (hGH) and insulin in 11 competitive weightlifters, ages 19 to 35 yrs. Three similar daily hGH peaks, seemingly preceded by a decrease in serum insulin concentration, were found during both amino acid and placebo supplementation. Supplementation did not affect the physiological variation of serum hGH concentration (treatment and treatment × time interaction:p=0.43–0.55). Analogously, serum insulin levels were not higher after amino acid supplementation. Therefore the ergogenic value of lowdose oral amino acid supplementation in increasing hGH or insulin secretion seems questionable.

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Subcutaneous Absorption Kinetics of Two Highly Concentrated Preparations of Recombinant Human Growth Hormone

Annals of Pharmacotherapy ◽

10.1177/106002809302700402 ◽

1993 ◽

Vol 27 (4) ◽

pp. 411-415 ◽

Cited By ~ 7

Author(s):

Torben Laursen ◽

Jens O.L. Jørgensen ◽

Søren Susgaard ◽

Jens Møller ◽

Jens S. Christiansen

Keyword(s):

Growth Hormone ◽

Human Growth Hormone ◽

Geometric Mean ◽

Human Growth ◽

Metabolic Effects ◽

Interindividual Variation ◽

Absorption Kinetics ◽

Short Term ◽

Significant Difference ◽

Relative Absorption

OBJECTIVE: The relative bioavailability of two highly concentrated (12 IU/mL) formulations of biosynthetic human growth hormone (GH) administered subcutaneously was compared. DESIGN: A randomized, crossover study. Conventional GH therapy was withdrawn 72 hours before each study period. There was a washout period of at least four weeks between the study periods. SETTING: Participants were recruited from an outpatient clinic and were hospitalized during the two study periods. PATIENTS: Fourteen GH-deficient patients (mean age 25.2 y, range 14–54). One patient was excluded from data analysis because of signs of endogenous GH secretion. INTERVENTIONS: At the start of each study period, GH 3 IU/m2 was injected subcutaneously. The two formulations, PenFill and PenSet, differ in the buffers used and in the relative content of mannitol and glycine. Serum profiles of GH were monitored frequently for 24 hours. Samples were taken every 30 minutes for 6 hours and then hourly. MAIN OUTCOME MEASURES: Bioavailability (F) and absorption dynamics of human GH were measured. The relative absorption fractions estimated from the areas under the individual serum concentration curves from 0 to 24 hours, and the observed time (Tmax) to reach the maximum concentration (Cmax) were determined. Short-term metabolic effects of GH on insulin-like growth factor (IGF-I), glucose, and insulin were determined. RESULTS: The geometric mean (SD) of F was 0.910 (1.236). The 90 percent confidence interval was 0.819–1.010. Mean (± SD) of Cmax was 12.65 ± 5.89 and 12.58 ± 4.40 ng/mL for PenFill and PenSet, respectively. Corresponding values for Tmax were 5.49 ± 1.55 and 5.89 ± 1.79 hours for PenFill and PenSet, respectively. There was a considerable interindividual variation, but the relative absorption fraction did not significantly differ from 1 (p=0.13). Neither Cmax (p=0.74) nor Tmax (p=0.58) of the two formulations was significantly different. Injection of the two formulations induced similar increments in serum IFG-I (p=0.48). Serum insulin and blood glucose concentrations were not significantly different. CONCLUSIONS: There is no significant difference between the absorption kinetics and short-term metabolic effects of these two highly concentrated formulations of biosynthetic GH. The two formulations are bioequivalent.

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METABOLIC EFFECTS OF SHORT TERM ADMINISTRATION OF HUMAN GROWTH HORMONE IN INFANCY AND EARLY CHILDHOOD

Acta Endocrinologica ◽

10.1530/acta.0.0440613 ◽

1963 ◽

Vol 44 (4) ◽

pp. 613-624 ◽

Cited By ~ 6

Author(s):

M. Vest ◽

J. Girard ◽

U. Bühler

Keyword(s):

Growth Hormone ◽

Human Growth Hormone ◽

Amino Nitrogen ◽

Human Growth ◽

Nitrogen Excretion ◽

Metabolic Effects ◽

Common Finding ◽

Short Term ◽

Term Administration ◽

Older Subjects

ABSTRACT The metabolic effects of short term administration of human growth hormone were studied in four infants two weeks to 2½ months old and three children 11 months to 3¼ years of age. They responded qualitatively in the same way as older children and hypopituitary dwarfs. Quantitatively the infants responded to a lesser extent than older subjects. The most constant findings are in order of decreasing response: Fall in urinary creatine, urea nitrogen and total nitrogen excretion and decreasing blood concentration of urea and residual nitrogen. An increase in α-amino-nitrogen excretion is also a fairly common finding. There is only a slight rise in the fasting level of free fatty acids in the serum in response to HGH injection in the infants. In the children this effect is already more pronounced. A fall in urinary sodium, potassium and phosphorus does not occur as regularly as in older subjects. An increase in ketone bodies in the urine was observed in some infants and children. The possible mechanisms and significance of the diminished response of infants to exogenous growth hormone are discussed.

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