Intranasal Insulin Treatment for Weight Management During Smoking Cessation

描述(由申请人提供)：戒烟后体重增加与再次吸烟的风险增加以及糖尿病的发展有关。到目前为止，还没有针对戒烟引起的体重增加的临床治疗方法。该项目建议测试鼻内胰岛素治疗在控制食物摄入量的行为和代谢方面的有效性。到目前为止，鼻腔胰岛素治疗表现出了特殊的安全性，初步数据表明，它对体重相关参数有好处。鼻腔给药直接将胰岛素输送到中枢神经系统，而不会有明显的外周吸收，从而导致低血糖事件。鼻腔注射胰岛素可以减少零食和循环中的游离脂肪酸--这些都是导致糖尿病发展的重要代谢物。这是一项第二阶段的人体实验研究，目的是为戒烟期间更大规模的鼻内胰岛素治疗第三阶段试验提供疗效数据。这项研究的受试者将参加两个疗程，在这两个疗程中，他们将接受鼻内胰岛素和安慰剂。吃完早餐后，他们的循环中的游离脂肪酸将被评估。我们假设与安慰剂相比，鼻腔注射胰岛素的患者游离脂肪酸水平较低。午餐后两个半小时，受试者将参加模拟品尝测试。他们将被告知，目标是对三种不同类型的饼干的适口性进行评级。评级后，受试者将被告知剩余的饼干将被丢弃，他们可以自由食用任何他们想吃的东西。我们假设，与安慰剂相比，治疗(鼻内注射胰岛素)条件下的饼干消耗量将会更低。该项目的里程碑包括证明鼻内胰岛素对尼古丁戒断期间的饱腹感和代谢状况的好处。

DESCRIPTION (provided by applicant): Weight gain following smoking cessation has been associated with increased risk of relapse to smoking as well as development of diabetes. To date, there are no clinical treatments that target weight gain caused by smoking cessation. This project proposes to test efficacy of intranasal insulin treatment in controlling behavioral and metabolic aspects of food intake. Thus far, intranasal insulin treatment has demonstrated an exceptional safety profile, and preliminary data indicate that it has benefits on weight-related parameters. Intranasal administration delivers insulin directly to the Central Nervous System, without a significant peripheral absorption that would cause hypoglycemic events. Intranasal insulin reduces snacking as well as circulating free fatty acids - metabolites that significantly contribute to the development of diabetes. This is a Phase II, human experimental study with a specific objective to provide efficacy data for a larger Phase III trial of intranasal insulin treatment during smoking cessation. Subjects in this study will participate in two sessions in which they will receive intranasal insulin and placebo. After eating breakfast, their circulating free fatty acids will be assessed. We hypothesize lower free fatty acids in the intranasal insulin vs. placebo condition. Two and a half hours after lunch, subjects will participate in a mock taste test. They will be told that the objective is to rate palatability of three different kinds of cookes. Following the ratings, subjects will be told that the remainder of cookies will be discarded and that they are free to eat however much they would like. We hypothesize that the cookie consumption in the treatment (intranasal insulin) condition will be lower in comparison to the placebo condition. Milestones for this project include demonstrating intranasal insulin's benefit on satiety and metabolic profile during nicotine withdrawal.