Effects of testosterone supplementation on whole body and regional fat mass and distribution in human immunodeficiency virus-infected men with abdominal obesity

Effects of testosterone supplementation on whole body and regional fat mass and distribution in human immunodeficiency virus-infected men with abdominal obesity
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DOI:
10.1210/jc.2006-2060
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发表时间:
2007-03-01
影响因子:
5.8
通讯作者:
Shikuma, Cecilia M.
Shikuma, Cecilia M.
中科院分区:
医学2区
文献类型:
--
作者:
Bhasin, Shalender;Parker, Robert A.;Shikuma, Cecilia M.

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背景:全身和腹部肥胖与糖尿病和心脏病的风险增加有关。睾酮治疗对HIV感染男性腹部肥胖患者全身和内脏脂肪量的影响尚不清楚。目的:本研究的目的是确定睾酮治疗对HIV感染男性腹部肥胖患者腹内脂肪量和全身脂肪分布的影响。方法:在这项多中心、随机、安慰剂对照、双盲试验中,88例HIV阳性男性腹部肥胖患者(腰臀比> 0.95或中腰围> 100 cm)和总睾酮125 - 400 ng/dl,或生物可利用睾酮小于115 ng/dl,或游离睾酮低于50 pg/ml,HIV RNA低于10,000拷贝/ml的患者随机接受睾酮凝胶或安慰剂治疗,每日10 g,疗程24 wk。在第0、12和24周,通过腹部计算机断层扫描和双能X线吸收法测定脂肪质量和分布。我们使用了意向治疗方法和非参数统计方法。结果:基线特征组间平衡。在评价的75例受试者中,两组间内脏脂肪从基线至第24周的中位百分比变化无显著差异(睾酮0.3%,安慰剂3.1%,P = 0.75)。睾酮治疗组男性的总(睾酮-1.5%,安慰剂4.3%,P = 0.04)和sc(睾酮-7.2%,安慰剂8.1%,P < 0.001)腹部脂肪量减少,但安慰剂组增加。通过双能X线吸收法测定,替吉奥治疗与全身、躯干和腹部脂肪量的显著减少相关(所有P < 0.001),而安慰剂组的全身和躯干脂肪量显著增加。在第24周,睾酮治疗组报告腹部(P = 0.01)、颈部(P = 0.08)和乳房尺寸(P = 0.01)减小的个体百分比显著高于安慰剂治疗组。睾酮治疗的男性比安慰剂有更大的瘦体重增加(睾酮1.3%,安慰剂-0.3,P = 0.02)。血浆胰岛素、空腹血糖、总高密度脂蛋白和低密度脂蛋白胆固醇水平无显著变化。Tehrine therapy was well tolerable.Conclusions:与安慰剂相比,在HIV阳性男性腹部肥胖和低睾酮患者中,Tehrine治疗与全身、总和皮下脂肪量的更大减少和瘦体重的更大增加相关。然而,组间内脏脂肪量的变化无显著差异。需要进一步的研究来确定睾酮对胰岛素敏感性和心血管风险的影响。
Background: Whole body and abdominal obesity are associated with increased risk of diabetes mellitus and heart disease. The effects of testosterone therapy on whole body and visceral fat mass in HIV-infected men with abdominal obesity are unknown.Objective: The objective of this study was to determine the effects of testosterone therapy on intraabdominal fat mass and whole body fat distribution in HIV-infected men with abdominal obesity.Methods: In this multicenter, randomized, placebo-controlled, double-blind trial, 88 HIV-positive men with abdominal obesity ( waist-to-hip ratio > 0.95 or mid-waist circumference > 100 cm) and total testosterone 125 - 400 ng/dl, or bioavailable testosterone less than 115 ng/dl, or free testosterone less than 50 pg/ml on stable antiretroviral regimen, and HIV RNA less than 10,000 copies per milliliter were randomized to receive 10 g testosterone gel or placebo daily for 24 wk. Fat mass and distribution were determined by abdominal computerized tomography and dual energy x-ray absorptiometry during wk 0, 12, and 24. We used an intention-to-treat approach and nonparametric statistical methods.Results: Baseline characteristics were balanced between groups. In 75 subjects evaluated, median percent change from baseline to wk 24 in visceral fat did not differ significantly between groups ( testosterone 0.3%, placebo 3.1%, P = 0.75). Total ( testosterone - 1.5%, placebo 4.3%, P = 0.04) and sc ( testosterone - 7.2%, placebo 8.1%, P < 0.001) abdominal fat mass decreased in testosterone-treated men, but increased in placebo group. Testosterone therapy was associated with significant decrease in whole body, trunk, and appendicular fat mass by dual energy x-ray absorptiometry ( all P < 0.001), whereas whole body and trunk fat increased significantly in the placebo group. The percent of individuals reporting a decrease in abdomen ( P = 0.01), neck ( P = 0.08), and breast size ( P = 0.01) at wk 24 was significantly greater in testosterone-treated than placebo-treated men. Testosterone-treated men had greater increase in lean body mass than placebo ( testosterone 1.3%, placebo - 0.3, P = 0.02). Plasma insulin, fasting glucose, and total high-density lipoprotein and low-density lipoprotein cholesterol levels did not change significantly. Testosterone therapy was well tolerated.Conclusions: Testosterone therapy in HIV-positive men with abdominal obesity and low testosterone was associated with greater decrease in whole body, total, and sc abdominal fat mass and a greater increase in lean mass compared to placebo. However, changes in visceral fat mass were not significantly different between groups. Further studies are needed to determine testosterone effects on insulin sensitivity and cardiovascular risk.