A randomized, open-label study to compare the effects of two different doses of recombinant human growth hormone on fat reduction and fasting metabolic parameters in HIV-1-infected patients with lipodystrophy.

Background Several studies have shown beneficial effects of recombinant human growth hormone (r-hGH) in reducing visceral adipose tissue (VAT) in HIV-1-infected patients with lipodystrophy. Methods Patients were randomized to r-hGH 4 mg daily (group A) or three times per week (group B) over 12 weeks, followed by a 2 mg daily maintenance dose for 12 weeks. Magnetic resonance imaging (MRI) scans were performed to assess body composition. Results A total of 26 subjects were included in the study. VAT was reduced overall by 35.1 cm² (29.5%) at week 12 and by 49 cm² (39.9%) at week 24, respectively, compared with baseline ( P<0.001 for both comparisons). By week 12, VAT was reduced by 27 and 29% (A vs B; P=0.47) while facial fat was reduced by 3.3 and 2.6 cm² in groups A and B, respectively ( P=0.96). Over 24 weeks, VAT was reduced by 42 and 38% ( P=0.35) and facial fat by 3.2 and 2.4 cm² in groups A and B, respectively ( P=0.91), compared with baseline. There was a greater increase in high-density lipoprotein (HDL) in group A than in group B (4.9 vs 2.4 mg/dL in week 12 and 7.1 vs −0.4 mg/dL in week 24; P=0.03). Fasting insulin levels increased, whereas glucose and insulin measured in oral glucose tolerance tests remained unchanged. Drug-related side effects were transient and reversible, but more common in group A (67%) than in group B (29%). Conclusions This study confirms reports that r-hGH effectively reduces VAT, with a relatively small reduction of facial and limb fat. [ABSTRACT FROM AUTHOR]