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TREATMENT WITH I-131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID

TREATMENT WITH I-131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID
I-131 间碘苄基胍治疗转移性类癌
批准号:
6243960
负责人:
JON P GOCKERMAN
金额:
$3.24万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
1975
资助国家:
美国
项目状态:
已结题
起止时间:
1975-10-01 至 1998-11-30

项目摘要

项目成果

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中文摘要
翻译
先前的研究表明,虽然放松训练可能有 对未经选择的非胰岛素患者样本影响不大 依赖型糖尿病(NIDDM),可能对改善 表现出高特质的个体的葡萄糖耐量 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)可以显著改善一组 NIDDM患者预先选择为高特质焦虑的个体。我们会 检查压力管理对糖尿病的急性和慢性影响 NIDDM患者高、低特质焦虑的对照研究 知觉焦虑变化与血液变化的关系 这些患者的血糖控制,此外,我们将进行 探索性分析确定患者是否存在压抑性应对 风格(低特质焦虑和高社交期望),也显示出 通过压力管理训练改善葡萄糖代谢。 方法:研究方法。我们使用2X2设计,高焦虑组和低焦虑组 焦虑组,每组随机分配一半接受 压力管理训练的干预。培训将是 在第一节课期间,以5个小组为单位,每周一次 学习一年中的两个月。所有受试者将每周上5节课-- 普通糖尿病教育(针对对照)和糖尿病教育加 压力管理培训(供实验者使用)。 所有受试者将接受为期一年的跟踪,评估以基线为基准, 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、葡萄糖刺激的胰岛素 反应,血浆高血糖素水平,空腹血糖/胰岛素, 血红蛋白A1c,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,新人格 Inventory和Marlowe Crown社交合意量表将是 仅按基线给药。 患有NIDDM的男性和女性不需要胰岛素治疗,将 参与进来。志愿者将首先使用STAI进行筛选。vbl.使用 成人普通内外科人群常模发表在 Stai手册(18),潜在的对象将被归类为 高、低或中等特质焦虑。得分在高的人 特质焦虑或低特质焦虑量表将被要求完成 整个研究。我们估计将需要360-400人来完成 Stai,以确定上下部各120名患者 三分一的特质焦虑。 符合高或低特质焦虑标准的志愿者将给予 同意并进行基线研究。他们也将被给予,并且 指导使用One Touch II血糖监测仪。 在基线研究之后,受试者将被随机分配到 压力管理培训或控制条件,并将安排 以一小群人开始他们每周的课程。意义重大。 在此之前,放松训练已被证明对 非胰岛素依赖型糖尿病的糖耐量与患者可观察到的更大影响 有高度的特质焦虑。这个项目将决定是否放松- 基于压力管理的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 这样的效果可以演示,然后我们就可以预选 对治疗有反应的个人。此外,成功地应用这一点 个体差异范式对糖尿病治疗的启示 对其他疾病,如高血压,采取类似的方法, 应该接受审判。计划。在过去的一年里,我们已经放映了200部 受试者(识别高特质焦虑和低特质焦虑的人)和 尝试将这些受试者登记到干预阶段 筛选工具上的>51或<27。因为人数很少 在这些分数范围内的筛选科目中,我们已经开始招生 所有受试者都经过筛查[感兴趣且愿意接受],不管他们是否焦虑 得分。
英文摘要
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.
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TREATMENT WITH I131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID
  • 批准号:
    6273981
  • 项目类别:
  • 资助金额:
    $2.88万
  • 财政年份:
    1997
  • 负责人:
    JON P GOCKERMAN
  • 依托单位:
PHASE I--TREATMENT WITH I-131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID
  • 批准号:
    5215612
  • 项目类别:
  • 资助金额:
    $0.0万
  • 财政年份:
    --
  • 负责人:
    JON P GOCKERMAN
  • 依托单位:
    --
TREATMENT WITH I131 METAIODOBENZYLGUANIDINE IN METASTATIC CARCINOID
  • 批准号:
    6112747
  • 项目类别:
  • 资助金额:
    $3.99万
  • 财政年份:
    --
  • 负责人:
    JON P GOCKERMAN
  • 依托单位:
海外基金