CLINICAL TRIAL: INSULIN SENSITIZERS AND LEPTIN IN HAART-INDUCED LIPATROPHY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 高效抗逆转录病毒治疗(HAART)经常导致体脂再分布、血脂异常和胰岛素抵抗。我们之前对HAART诱导的代谢综合征患者的研究表明：1)服用吡格列酮12个月以上可有利地改变胰岛素抵抗、血压和血脂状况，2)生理剂量的R-metHuLeptin替代改善HAART诱导的脂肪萎缩的胰岛素抵抗。本研究的目的是评估吡格列酮和/或瘦素对HAART诱导的脂肪变性的治疗是否有效和安全，以及联合使用瘦素和吡格列酮对HAART诱导的脂肪变性中的胰岛素抵抗、高脂血症、体成分和心血管危险因素是否具有相加或相乘作用。这是一项针对HAART诱导的脂肪萎缩的HIV感染患者的随机、双盲、安慰剂对照试验。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Highly active antiretroviral therapy (HAART) frequently results in body fat redistribution, dyslipidemia, and insulin resistance. Our previous studies in patients with HAART-induced metabolic syndrome showed that: 1) Pioglitazone administration over 12 months alters insulin resistance, blood pressure and lipid profile favorably, 2) R-metHuLeptin replacement at physiologic doses improves insulin resistance in HAART-induced lipoatrophy. The objective of this study is to evaluate whether pioglitazone and/or leptin are effective and safe for the treatment of HAART-induced lipatrophy and whether the combination of leptin and pioglitazone has an additive or multiplicative effect on insulin resistance, hyperlipidemia, body composition and cardiovascular risk factors in HAART-induced lipatrophy. This is a randomized, double-blind, placebo-controlled trial of HIV-infected patients with HAART-induced lipoatrophy.