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Growth Hormone Treatment Prevents Loss of Lean Mass after Bariatric Surgery in Morbidly Obese Patients: Results of a Pilot, Open, Prospective, Randomized, Controlled Study

Department of Molecular and Clinical Endocrinology and Oncology (S.S., C.D.S., F.O., G.L., A.C.), Division of Endocrinology, University Federico II of Naples, 80131 Naples, Italy; Department of Surgery (L.A.), S. Giovanni Bosco Hospital of Naples, 80144 Naples, Italy; Endocrinology University Parthenope Naples (F.O.), 80133 Naples, Italy; and Department of Medical Affairs Merck-Serono Italia (S.L.), 00176 Rome, Italy

Address all correspondence and requests for reprints to: Annamaria Colao, M.D., Ph.D., Department of Molecular & Clinical Endocrinology and Oncology, "Federico II" University of Naples, via S. Pansini 5, 80131 Naples, Italy. E-mail: colao{at}unina.it.

Context: The loss of lean body mass (LBM) negatively influences the outcome in bariatric surgery. Impaired GH secretion is frequent in obese patients.

Objective: Our objective was to investigate if GH treatment prevents LBM loss in the early postoperative period.

Design: This was an open, prospective, randomized, and controlled study.

Patients: A total of 24 women (body mass index: 44.4 ± 7.6 kg/m², aged 36.8 ± 11.7 yr) undergoing laparoscopic-adjustable silicone gastric banding (LASGB) and with GH deficiency after LASGB was included in the study.

Treatment Protocol: Group A (n = 12) included a standardized diet regimen and exercise program plus recombinant human GH (0.5 ± 0.13 mg every day), and group B (n = 12) included a standardized diet regimen and exercise program. The follow-up duration was 6 months.

Results: The excess of body weight loss did not differ between groups A and B after 3 and 6 months. At 3 months, LBM loss was lower (P < 0.0001) and fat mass (FM) loss was higher (P = 0.02) in group A than group B. At 3 and 6 months, appendicular skeletal muscle mass loss was lower (P = 0.000) in group A than group B. At 3 (P = 0.0003 and 0.0005, respectively) and 6 months (P < 0.0001 and 0.0002, respectively), the percent changes of FM and lean body mass were significantly higher in group A than group B. In both groups fasting and postglucose area under the plasma concentration-time curve insulin significantly reduced. The homeostasis model assessment of insulin and insulin sensitivity indexes and total to high-density lipoprotein cholesterol ratio improved only in group A.

Conclusions: GH treatment for 6 months after LASGB reduces loss in LBM and appendicular skeletal muscle mass during a standardized program of low-calorie diet and physical exercise program, with improvement of lipid profile and without a deterioration of glucose tolerance.