Human Growth hormone HGH replacement therapy in adult-onset hgh deficiency: effects on body composition in men and women in a double-blind, randomized, placebo-controlled trial.
Hoffman AR - J Clin Endocrinol Metab - 01-MAY-2004; 89(5): 2048-56
From NIH/NLM MEDLINE
NLM Citation ID:
15126520 (PubMed)
Full Source Title:
Journal of Clinical Endocrinology and Metabolism
Publication Type:
Clinical Trial; Journal Article; Randomized Controlled Trial
Language:
English
Author Affiliation:
Veterans Affairs Palo Alto Health Care System and Stanford University, Palo Alto, California 94304, USA. arhoffman@stanford.edu
Authors:
Hoffman AR; Kuntze JE; Baptista J; Baum HB; Baumann GP; Biller BM; Clark RV; Cook D; Inzucchi SE; Kleinberg D; Klibanski A; Phillips LS; Ridgway EC; Robbins RJ; Schlechte J; Sharma M; Thorner MO; Vance ML
Abstract:
Adult HGH deficiency (AGHD) is characterized by an altered body composition, an atherogenic lipid profile, decreased exercise capacity, and diminished quality of life. We performed a randomized, double-blind, placebo-controlled, multicenter study in 166 subjects with AGHD to assess the effects of HGH on these outcomes. HGH was initiated at 0.0125 mg/kg.d, increased to 0.025 mg/kg.d as tolerated, or decreased to 0.00625 mg/kg.d for 12 months. Primary measures of efficacy included body composition, strength and endurance, and quality of life. Additional parameters included serum IGF-I concentrations, serum lipids, and bone mineral density. After 12 months, 79% of subjects remained on HGH 0.0125 mg/kg.d, whereas 21% received 0.00625 mg/kg.d. HGH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline. In GH-treated men, mean IGF-I SD scores exceeded age-adjusted normal ranges, whereas similar doses produced a smaller response in women. HGH treatment was associated with significant improvements in total cholesterol and low-density lipoprotein (P < 0.05 for all). No significant treatment effects were observed in strength and endurance, quality of life, or bone mineral density. HGH treatment was generally well tolerated. Subjects with AGHD should receive individualized HGH therapy to maintain IGF-I between the mean value and +2 SD and improve body composition and cardiovascular risk factors.
Major Subjects:
- Body Composition / * drug effects
- Human Growth Hormone / administration & dosage / adverse effects / * deficiency / * therapeutic use
Additional Subjects:
- Adult
- Aged
- Anthropometry
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Insulin-Like Growth Factor I / metabolism
- Lipids / blood
- Male
- Metabolism, Inborn Errors / drug therapy / pathology / physiopathology
- Middle Aged
- Muscle, Skeletal / physiopathology
- Physical Endurance
- Placebos
- Quality of Life
- Recombinant Proteins / administration & dosage / adverse effects / therapeutic use
- Research Support, Non-U.S. Gov't
Chemical Compound Name:
(Lipids); (Placebos); (Recombinant Proteins); 12629-01-5(Human Growth Hormone); 67763-96-6(Insulin-Like Growth Factor I)