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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
Author(s) -
Bickel M,
Zangos S,
Jacobi V,
Lutz T,
Knecht G,
Goebel F,
Staszewski S,
Klauke S
Publication year - 2006
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2006.00399.x
Subject(s) - medicine , lipodystrophy , endocrinology , adipose tissue , insulin , human immunodeficiency virus (hiv) , antiretroviral therapy , viral load , family medicine
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 cm 2 (29.5%) at week 12 and by 49 cm 2 (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 cm 2 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 cm 2 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.