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 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.
Bickel
M
M
HIV Treatment and Research Unit, JW Goethe University, Frankfurt, Germany. markusbickel@hotmail.com
Zangos
S
S
Jacobi
V
V
Lutz
T
T
Knecht
G
G
Goebel
F
F
Staszewski
S
S
Klauke
S
S
D000273:Adipose Tissue / Q000033:anatomy & histology / Q000187:drug effects; D001823:Body Composition / Q000187:drug effects; D005215:Fasting / Q000378:metabolism; D005260:Female; D015658:HIV Infections / Q000150:complications; D015497:HIV-1; D039682:HIV-Associated Lipodystrophy Syndrome / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome
D011994:Recombinant Proteins; D019382:Human Growth Hormone