TREATMENT WITH I-131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID

先前的研究表明，虽然放松训练可能会 对非胰岛素依赖患者的样本几乎没有影响 依赖性糖尿病（NIDDM），它可能是有效的改善 葡萄糖耐量高的个体亚组 焦虑 拟议调查的主要目的是 确定基于放松的压力管理疗法（压力 管理）可以显着改善代谢控制在一组 预先选择高特质焦虑的NIDDM患者。 我们将 研究压力管理对糖尿病的急性和慢性影响 对照高、低特质焦虑的NIDDM患者， 感知焦虑的变化与血液变化的关系 这些患者的血糖控制，此外，我们将执行 探索性分析，以确定是否有压抑性应对的患者 风格（低特质焦虑和高社会期望），也表明 在压力下改善葡萄糖代谢 管理培训。 方法.我们采用2 × 2设计，高焦虑组和低焦虑组， 焦虑组，每组中的一半被随机分配接受 压力管理训练干预。 培训将 在第一阶段每隔一周进行5个小组班， 研究年度的2个月。 所有受试者将参加每周5次的课程- 一般糖尿病教育（对照组）和糖尿病教育+ 压力管理训练（实验对象）。 所有受试者将随访1年，在基线时进行评估， 2个月、4个月、6个月、9个月（电话）和12个月。 变量包括葡萄糖耐量、葡萄糖刺激胰岛素 反应、血浆胰高血糖素水平、空腹血糖/胰岛素， 血红蛋白A1 c，果糖胺，感知焦虑/压力水平， 家庭监测血糖的平均值/变异性，饮食分析， 学习[糖尿病教育和压力管理内容]，锻炼 水平除了这些，历史和体检，NEO个性 库存和马洛皇冠社会可取性量表将是 仅在基线时给药。 不需要胰岛素治疗的NIDDM男性和女性， 参加志愿者将首先使用STAI进行筛选。 使用 成人普通内科-外科人群的标准 根据STAI手册（18），潜在受试者将被分为以下三分之一： 高、低或中度特质焦虑。 高分者 将要求特质焦虑或低特质焦虑三分位数完成 整个研究。 我们估计360-400人将需要完成 STAI，以确定120例患者（各）的上和下 三分之一的特质焦虑 符合高或低特质焦虑标准的志愿者将给予 同意并接受基线研究。 他们也将被给予， 指导使用One Touch II血糖监测仪。 基线研究后，受试者将被随机分配至 压力管理培训或控制状况，并将安排 开始他们每周的会议与一个小组队列。 意义 放松训练以前已经被证明对 在NIDDM患者中观察到更大的影响 高焦虑症患者 这个项目将决定是否放松- 基于压力管理计划可以有临床意义的长期- 长期对高特质焦虑患者血糖控制的影响如果 这样的效果可以被证明，那么我们将能够预先选择 对治疗有反应的个体。 此外，成功应用这一 糖尿病治疗的个体差异范例将建议 用类似的方法治疗其他疾病，比如高血压， 应该受到审判。布局 在过去的一年里，我们筛选了200个 受试者（识别具有高和低特质焦虑的受试者）和 尝试入组干预阶段的受试者得分 在筛选工具上>51或<27。 因为人数少 在这些评分范围内筛选的受试者中，我们已开始入组 所有筛选的[感兴趣和愿意]受试者，不考虑焦虑 成绩.

Previous research has suggested that while relaxation training may have little effect on an unselected sample of patients with non-insulin dependent diabetes mellitus (NIDDM), it may be effective in improving glucose tolerance in the subset of individuals who show high Trait Anxiety. The primary purpose of the proposed investigation is to determine if a relaxation-based stress management therapy (stress management) can significantly improve metabolic control in a group of individuals with NIDDM pre-selected for high Trait Anxiety. We will examine the acute and chronic effects of stress management on diabetes control in high and low Trait Anxiety patients with NIDDM, determine the relationship between changes in perceived anxiety and changes in blood glucose control in these patients and, in addition, we will perform exploratory analyses to determine if patients with repressive coping style (low Trait Anxiety and high social desirability), also show improvements in glucose metabolism with stress management training. Methods. We use a 2 X 2 design with a high anxious group and a low anxious group, half of each group randomly assigned to receive the intervention of stress management training. The training will be conducted in 5, small-group classes at weekly intervals during the first 2 months of the study year. All subjects will attend 5 weekly classes-- general diabetes education (for controls) and diabetes education plus stress management training (for experimentals). All subjects will be followed for 1 year, with assessments at baseline, 2 months, 4 months, 6 months, 9 months (phone) and 12 months. Variables include glucose tolerance, glucose stimulated insulin response, plasma glucagon levels, fasting plasma glucose/insulin, hemoglobin A1c, fructosamine, perceived anxiety/stress level, mean/variability of home-monitored blood glucose, diet analysis, learning [of diabetes education and stress management content], exercise level. In addition to these, history and physical exam, NEO Personality Inventory and Marlowe Crown Social Desirability Scale will be administered at baseline only. Men and women with NIDDM not requiring insulin treatment, will participate. Volunteers will first be screened using the STAI. Using norms for an adult general medical-surgical population published in the STAI manual (18), potential subjects will be classified into tertiles of high, low or moderate Trait Anxiety. Persons with scores in the high Trait Anxiety or low Trait Anxiety tertiles will be asked to complete the entire study. We estimate 360-400 people will need to complete the STAI in order to define 120 patients (each) in the upper and lower tertiles of Trait anxiety. Volunteers that meet high or low Trait anxiety criteria will give consent and undergo baseline studies. They will also be given, and instructed in the use of, a One Touch II blood glucose monitor. Following baseline studies, subjects will be randomly assigned to stress management training or control condition, and will be scheduled to begin their weekly sessions with a small group cohort. Significance. Relaxation training has been previously shown to have acute effects on glucose tolerance in NIDDM with greater effects observable in patients with high Trait Anxiety. This project will determine if a relaxation- based stress management program can have a clinically meaningful long- term impact on blood glucose control in high trait-anxious patients. If such an effect can be demonstrated, then we will be able to pre-select treatment responsive individuals. In addition, success in applying this individual difference paradigm to the treatment of diabetes will suggest that similar approaches with other diseases, such as hypertension, should be tried. Plans. Over the past year we have screened 200 subjects (identifying those with High and Low trait anxiety) and attempted to enroll in the intervention phase those subjects scoring either >51 or <27 on the screening tool. Because of the small numbers of screened subjects in these score ranges, we have started to enroll all screened [interested and willing] subjects regardless of anxiety scores.