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Low-Dose Recombinant Human Growth Hormone as Adjuvant Therapy to Lifestyle Modifications in the Management of Obesity

Division of Endocrinology, Diabetes, and Metabolism, Department of Internal Medicine, St. Louis University School of Medicine, St. Louis, Missouri 63104

Address all correspondence and requests for reprints to: Stewart G. Albert, M.D., Department of Internal Medicine, Division of Endocrinology, St. Louis University Health Science Center, 1402 South Grand Boulevard, St. Louis, Missouri 63104. E-mail: albertsg{at}slu.edu.

Obese individuals are in a reduced GH/IGF-I state that may be maladaptive. Fifty-nine obese men and premenopausal menstruating women (body mass index, 36.9 ± 5.0 kg/m²) were randomized to a double-blind, placebo-controlled trial of low dose recombinant human GH (rhGH). During the 6-month intervention, subjects self-administered daily rhGH or equivalent volume of placebo at 200 µg (1.9 ± 0.3 µg/kg for men, 2.0 ± 0.3 µg/kg for women); after 1 month, the dose was increased to 400 µg (3.8 ± 0.5 µg/kg) in men and 600 µg (6.0 ± 0.8 µg/kg) in women. rhGH was then discontinued, and subjects were followed up after 3 months. Forty completed the intervention, and 39 completed the follow-up. Drop-out rates between rhGH vs. placebo groups were not different (² = 1.45; P = 0.228). One subject discontinued the drug due to an rhGH-related side effect. Body weight (BW) decreased with rhGH from 100.4 ± 13.2 to 98.0 ± 15.6 kg at 6 months (P = 0.04) and was sustained at 98.1 ± 16.6 kg at 9 months (P = 0.02). BW loss was entirely due to loss of body fat (BF). Intention to treat analyses demonstrated changes from baseline between rhGH and placebo in BW (-2.16 ± 4.48 vs. -0.04 ± 2.67 kg; P = 0.03) and BF (-2.89 ± 3.76 vs. -0.68 ± 2.37 kg; P = 0.01). rhGH increased IGF-I from -0.72 to +0.10 SD (P = 0.0001). rhGH increased high-density lipoprotein cholesterol 19% from 1.11 ± 0.34 to 1.32 ± 0.28 mmol/liter (P < 0.001). Neither group had changes in fasting glucose, insulin sensitivity, or resting energy expenditure. In conclusion, in obesity, rhGH normalized IGF-I levels, induced loss of BW from BF, and improved lipid profile without untoward effects on insulin sensitivity.

This work was supported in part by a grant from Pfizer, Inc.

Abbreviations: BF, Body fat; BW, body weight; HDL, high-density lipoprotein; HOMA, homeostasis model assessment; LBM, lean body mass; LDL, low-density lipoprotein; REE, resting energy expenditure; rhGH, recombinant human GH; VLDL, very LDL.

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