CONTEXT: Reduced growth hormone (GH) concentrations are observed in men with human immunodeficiency virus (HIV) lipodystrophy. OBJECTIVE: To investigate the effects of growth hormone-releasing hormone (GHRH), a GH secretagogue, in treatment of HIV lipodystrophy. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial conducted at a research center in the United States between October 2002 and June 2003 and enrolling 31 HIV-infected men aged 18 to 60 years with evidence of lipodystrophy. INTERVENTIONS: Participants were assigned to receive GHRH (1 mg subcutaneously twice daily) or placebo for 12 weeks. MAIN OUTCOME MEASURES: The primary outcome was change in concentrations of insulin-like growth factor 1 (IGF-1) to detect overall change in GH levels in response to GHRH. Secondary end points included body composition by dual-energy x-ray absorptiometry and computed tomography, lipodystrophy ratings, and levels of glucose, insulin, and lipids. RESULTS:Mean (SD) IGF-1 concentrations increased significantly in the GHRH group vs the placebo group (104 [110] ng/mL vs 6 [44] ng/mL, P =.004). Lean body mass significantly increased in the GHRH group vs the placebo group (0.9 [1.3] kg vs -0.3 [1.7] kg, P =.04), trunk fat significantly decreased (-0.4 [0.7] kg vs 0.2 [0.6] kg, P =.03), and the ratio of trunk to lower extremity fat improved significantly (-0.22 [0.32] vs 0.14 [0.29], P =.005). Abdominal visceral fat was reduced (-19.2 [36.6] cm2 vs 2.3 [24.3] cm2, P =.07) and the ratio of abdominal visceral fat to abdominal subcutaneous fat improved significantly more in the GHRH group (-0.19 [0.28] vs 0.07 [0.27], P =.02). Both physician and patient rating of lipodystrophy in the arms, legs, and abdomen also improved significantly. Levels of glucose, insulin, and lipids did not change significantly. CONCLUSIONS:GHRH was well tolerated and effectively increased levels of IGF-1 in HIV-infected men with lipodystrophy. Total and regional body composition improved in response to GHRH, with increased lean mass and reduced truncal and visceral fat. Use of GHRH may potentially be a beneficial treatment strategy for this population.
RCT Entities:
CONTEXT: Reduced growth hormone (GH) concentrations are observed in men with human immunodeficiency virus (HIV) lipodystrophy. OBJECTIVE: To investigate the effects of growth hormone-releasing hormone (GHRH), a GH secretagogue, in treatment of HIV lipodystrophy. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial conducted at a research center in the United States between October 2002 and June 2003 and enrolling 31 HIV-infectedmen aged 18 to 60 years with evidence of lipodystrophy. INTERVENTIONS:Participants were assigned to receive GHRH (1 mg subcutaneously twice daily) or placebo for 12 weeks. MAIN OUTCOME MEASURES: The primary outcome was change in concentrations of insulin-like growth factor 1 (IGF-1) to detect overall change in GH levels in response to GHRH. Secondary end points included body composition by dual-energy x-ray absorptiometry and computed tomography, lipodystrophy ratings, and levels of glucose, insulin, and lipids. RESULTS: Mean (SD) IGF-1 concentrations increased significantly in the GHRH group vs the placebo group (104 [110] ng/mL vs 6 [44] ng/mL, P =.004). Lean body mass significantly increased in the GHRH group vs the placebo group (0.9 [1.3] kg vs -0.3 [1.7] kg, P =.04), trunk fat significantly decreased (-0.4 [0.7] kg vs 0.2 [0.6] kg, P =.03), and the ratio of trunk to lower extremity fat improved significantly (-0.22 [0.32] vs 0.14 [0.29], P =.005). Abdominal visceral fat was reduced (-19.2 [36.6] cm2 vs 2.3 [24.3] cm2, P =.07) and the ratio of abdominal visceral fat to abdominal subcutaneous fat improved significantly more in the GHRH group (-0.19 [0.28] vs 0.07 [0.27], P =.02). Both physician and patient rating of lipodystrophy in the arms, legs, and abdomen also improved significantly. Levels of glucose, insulin, and lipids did not change significantly. CONCLUSIONS:GHRH was well tolerated and effectively increased levels of IGF-1 in HIV-infectedmen with lipodystrophy. Total and regional body composition improved in response to GHRH, with increased lean mass and reduced truncal and visceral fat. Use of GHRH may potentially be a beneficial treatment strategy for this population.
Authors: D J Brick; A V Gerweck; E Meenaghan; E A Lawson; M Misra; P Fazeli; W Johnson; A Klibanski; K K Miller Journal: Eur J Endocrinol Date: 2010-05-25 Impact factor: 6.664
Authors: Carlos M Reyes-Vidal; Hamed Mojahed; Wei Shen; Zhezhen Jin; Fernando Arias-Mendoza; Jean Carlos Fernandez; Dympna Gallagher; Jeffrey N Bruce; Kalmon D Post; Pamela U Freda Journal: J Clin Endocrinol Metab Date: 2015-06-02 Impact factor: 5.958
Authors: Catherine Beauregard; Andrea L Utz; Amber E Schaub; Lisa Nachtigall; Beverly M K Biller; Karen K Miller; Anne Klibanski Journal: J Clin Endocrinol Metab Date: 2008-04-01 Impact factor: 5.958
Authors: Pamela U Freda; Wei Shen; Steven B Heymsfield; Carlos M Reyes-Vidal; Eliza B Geer; Jeffrey N Bruce; Dympna Gallagher Journal: J Clin Endocrinol Metab Date: 2008-03-18 Impact factor: 5.958