Metabolic effects of a growth hormone-releasing factor in obese subjects with reduced growth hormone secretion: a randomized controlled trial.
Level 2 - randomized trial
Individual randomized double-blind placebo-controlled trial.
PubMed 23015655 · doi:10.1210/jc.2012-2794
What was done
Sixty abdominally obese subjects with reduced growth hormone secretion were enrolled in a randomized, double-blind, placebo-controlled trial. Participants received either tesamorelin (a GHRH(1-44) analog, 2 mg daily) or placebo for 12 months. Visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) were assessed by abdominal computed tomography scan, and carotid intima-media thickness (cIMT) was measured with ultrasound. Treatment effects were evaluated using longitudinal linear mixed-effects modeling.
What was found
Compared with placebo, tesamorelin significantly reduced VAT (-16 ± 9 vs 19 ± 9 cm2; treatment effect: -35 cm2, 95% CI -58 to -12, P = 0.003), cIMT (-0.03 ± 0.01 vs 0.01 ± 0.01 mm; treatment effect: -0.04 mm, 95% CI -0.07 to -0.01, P = 0.02), log C-reactive protein (-0.17 ± 0.04 vs -0.03 ± 0.05 mg/L; treatment effect: -0.15 mg/L, 95% CI -0.30 to -0.01, P = 0.04), and triglycerides (-26 ± 16 vs 12 ± 8 mg/dL; treatment effect: -37 mg/dL, 95% CI -67 to -7, P = 0.02). IGF-I increased in the tesamorelin group (treatment effect: 92 ug/L, 95% CI 52 to 132, P < 0.0001). No significant changes were observed in abdominal SAT (-6 ± 6 vs 3 ± 11 cm2, P = 0.40) or in fasting glucose, 2-hour glucose, and glycated hemoglobin. There were no serious adverse events or differences in adverse events between groups.
Why it matters
Augmenting endogenous growth hormone with tesamorelin selectively decreases visceral adiposity and improves cardiovascular risk markers without inducing adverse glycemic effects in obese patients with low growth hormone secretion.
Limits
The sample size was small (n = 60), limiting precision and power for secondary outcomes. The study was restricted to individuals with abdominal obesity and confirmed low growth hormone secretion, limiting generalizability to the broader obese population. Hard cardiovascular clinical outcomes were not evaluated.
Cited by
- supports Tesamorelin stimulates growth hormone release and is uniquely effective at reducing visceral abdominal fat.