CONTEXT: Data regarding gender-specific efficacy of GH on critical endpoints are lacking. There are no randomized, placebo-controlled studies of physiological GH therapy solely in women. OBJECTIVE: Our objective was to determine the effects of physiological GH replacement on cardiovascular risk markers and body composition in women with GH deficiency (GHD). DESIGN: This was a 6-month, randomized, placebo-controlled, double-blind study. SETTING: The study was conducted at the General Clinical Research Center. STUDY PARTICIPANTS: 43 women with GHD due to hypopituitarism were included in the study. INTERVENTION: Study participants were randomized to receive GH (goal mid-normal serum IGF-1) or placebo. MAIN OUTCOME MEASURES: Cardiovascular risk markers, including high-sensitivity C-reactive protein, tissue plasminogen activator, and body composition, including visceral adipose tissue by cross-sectional computed tomography, were measured. RESULTS: Mean daily GH dose was 0.67 mg. The mean IGF-1 sd score increased from -2.5 +/- 0.3 to -1.4 +/- 0.9 (GH) (P < 0.0001 vs. placebo). High-sensitivity C-reactive protein decreased by 38.2 +/- 9.6% (GH) vs.18.2 +/- 6.0% (placebo) (P = 0.03). Tissue plasminogen activator and total cholesterol decreased, and high-density lipoprotein increased. Homeostasis model assessment-insulin resistance and other markers were unchanged. Body fat decreased [-5.1 +/- 2.0 (GH) vs. 1.9 +/- 1.0% (placebo); P = 0.002] as did visceral adipose tissue [-9.0 +/- 5.9 (GH) vs. 4.3 +/- 2.7% (placebo); P = 0.03]. Change in IGF-1 level was inversely associated with percent change in visceral adipose tissue (r = -0.61; P = 0.002), total body fat (r = -0.69; P < 0.0001), and high-sensitivity C-reactive protein (r = -0.51; P = 0.003). CONCLUSIONS: Low-dose GH replacement in women with GHD decreased total and visceral adipose tissue and improved cardiovascular markers, with a relatively modest increase in IGF-1 levels and without worsening insulin resistance.
RCT Entities:
CONTEXT: Data regarding gender-specific efficacy of GH on critical endpoints are lacking. There are no randomized, placebo-controlled studies of physiological GH therapy solely in women. OBJECTIVE: Our objective was to determine the effects of physiological GH replacement on cardiovascular risk markers and body composition in women with GH deficiency (GHD). DESIGN: This was a 6-month, randomized, placebo-controlled, double-blind study. SETTING: The study was conducted at the General Clinical Research Center. STUDY PARTICIPANTS: 43 women with GHD due to hypopituitarism were included in the study. INTERVENTION: Study participants were randomized to receive GH (goal mid-normal serum IGF-1) or placebo. MAIN OUTCOME MEASURES: Cardiovascular risk markers, including high-sensitivity C-reactive protein, tissue plasminogen activator, and body composition, including visceral adipose tissue by cross-sectional computed tomography, were measured. RESULTS: Mean daily GH dose was 0.67 mg. The mean IGF-1 sd score increased from -2.5 +/- 0.3 to -1.4 +/- 0.9 (GH) (P < 0.0001 vs. placebo). High-sensitivity C-reactive protein decreased by 38.2 +/- 9.6% (GH) vs.18.2 +/- 6.0% (placebo) (P = 0.03). Tissue plasminogen activator and total cholesterol decreased, and high-density lipoprotein increased. Homeostasis model assessment-insulin resistance and other markers were unchanged. Body fat decreased [-5.1 +/- 2.0 (GH) vs. 1.9 +/- 1.0% (placebo); P = 0.002] as did visceral adipose tissue [-9.0 +/- 5.9 (GH) vs. 4.3 +/- 2.7% (placebo); P = 0.03]. Change in IGF-1 level was inversely associated with percent change in visceral adipose tissue (r = -0.61; P = 0.002), total body fat (r = -0.69; P < 0.0001), and high-sensitivity C-reactive protein (r = -0.51; P = 0.003). CONCLUSIONS: Low-dose GH replacement in women with GHD decreased total and visceral adipose tissue and improved cardiovascular markers, with a relatively modest increase in IGF-1 levels and without worsening insulin resistance.
Authors: F Borson-Chazot; A Serusclat; Y Kalfallah; X Ducottet; G Sassolas; S Bernard; F Labrousse; J Pastene; A Sassolas; Y Roux; F Berthezène Journal: J Clin Endocrinol Metab Date: 1999-04 Impact factor: 5.958
Authors: J W Tomlinson; N Holden; R K Hills; K Wheatley; R N Clayton; A S Bates; M C Sheppard; P M Stewart Journal: Lancet Date: 2001-02-10 Impact factor: 79.321
Authors: E Bonora; G Targher; M Alberiche; R C Bonadonna; F Saggiani; M B Zenere; T Monauni; M Muggeo Journal: Diabetes Care Date: 2000-01 Impact factor: 19.112
Authors: A Katz; S S Nambi; K Mather; A D Baron; D A Follmann; G Sullivan; M J Quon Journal: J Clin Endocrinol Metab Date: 2000-07 Impact factor: 5.958
Authors: G Sesmilo; B M Biller; J Llevadot; D Hayden; G Hanson; N Rifai; A Klibanski Journal: J Clin Endocrinol Metab Date: 2001-04 Impact factor: 5.958
Authors: Mark L Hartman; Brenda J Crowe; Beverly M K Biller; Ken K Y Ho; David R Clemmons; John J Chipman Journal: J Clin Endocrinol Metab Date: 2002-02 Impact factor: 5.958
Authors: Miriam A Bredella; Eleanor Lin; Danielle J Brick; Anu V Gerweck; Lindsey M Harrington; Martin Torriani; Bijoy J Thomas; David A Schoenfeld; Anne Breggia; Clifford J Rosen; Linda C Hemphill; Zida Wu; Nader Rifai; Andrea L Utz; Karen K Miller Journal: Eur J Endocrinol Date: 2012-01-24 Impact factor: 6.664
Authors: E Lin; T L Wexler; L Nachtigall; N Tritos; B Swearingen; L Hemphill; J Loeffler; B M K Biller; A Klibanski; K K Miller Journal: Clin Endocrinol (Oxf) Date: 2012-09 Impact factor: 3.478
Authors: Darlene E Berryman; Jens Sandahl Christiansen; Gudmundur Johannsson; Michael O Thorner; John J Kopchick Journal: Growth Horm IGF Res Date: 2008-08-16 Impact factor: 2.372
Authors: Rita Sharma; Quyen Luong; Vishva M Sharma; Mitchell Harberson; Brian Harper; Andrew Colborn; Darlene E Berryman; Niels Jessen; Jens Otto Lunde Jørgensen; John J Kopchick; Vishwajeet Puri; Kevin Y Lee Journal: J Endocrinol Date: 2018-12-01 Impact factor: 4.286
Authors: Elena Valassi; Danielle J Brick; Jessica C Johnson; Beverly M K Biller; Anne Klibanski; Karen K Miller Journal: Endocr Pract Date: 2012 Mar-Apr Impact factor: 3.443