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

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 高效抗逆转录病毒治疗（HAART）经常导致身体脂肪重新分布，血脂异常和胰岛素抵抗。 我们先前在HAART诱导的代谢综合征患者中的研究表明：1）吡格列酮给药超过12个月可有利地改变胰岛素抵抗、血压和血脂谱，2）生理剂量的R-metHuLeptin替代可改善HAART诱导的脂肪萎缩中的胰岛素抵抗。 本研究的目的是评价吡格列酮和/或瘦素治疗HAART诱导的脂肪变性是否有效和安全，以及瘦素和吡格列酮联合治疗HAART诱导的脂肪变性是否对胰岛素抵抗、高脂血症、身体组成和心血管危险因素具有累加或倍增效应。 这是一项随机、双盲、安慰剂对照试验，研究对象为HAART诱导的脂肪萎缩的HIV感染患者。

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.