Intranasal Insulin Treatment for Weight Management During Smoking Cessation

描述（由申请人提供）：戒烟后体重增加与吸烟复发风险增加以及糖尿病发展相关。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。该项目旨在测试鼻内胰岛素治疗在控制食物摄入的行为和代谢方面的功效。到目前为止，鼻内胰岛素治疗已证明了一个特殊的安全性，初步数据表明，它对体重相关参数的好处。鼻内给药将胰岛素直接递送至中枢神经系统，而没有会引起低血糖事件的显著外周吸收。鼻内胰岛素减少零食以及循环游离脂肪酸-代谢产物，显着促进糖尿病的发展。这是一项II期人体实验研究，其特定目的是为戒烟期间鼻内胰岛素治疗的更大III期试验提供疗效数据。本研究中的受试者将参加两个阶段，期间他们将接受鼻内胰岛素和安慰剂治疗。吃早餐后，将评估他们的循环游离脂肪酸。我们假设鼻内胰岛素与安慰剂相比游离脂肪酸较低。午餐后两个半小时，受试者将参加模拟味觉测试。他们将被告知，目的是评价三种不同种类的厨师的适口性。在评级之后，受试者将被告知剩余的饼干将被丢弃，他们可以自由地吃他们想吃的东西。我们假设治疗（鼻内胰岛素）条件下的饼干消耗量低于安慰剂条件。该项目的重要性包括证明鼻内胰岛素在尼古丁戒断期间对饱腹感和代谢特征的益处。

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.