Non-invasive Assessment of Insulin Resistance

胰岛素抵抗的无创评估

基本信息

  • 批准号:
    8115973
  • 负责人:
  • 金额:
    $ 29.53万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2005
  • 资助国家:
    美国
  • 起止时间:
    2005-09-15 至 2013-07-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): The overall objective of this grant is to develop a non-invasive method for assessment of insulin resistance and impaired glucose tolerance (IGT) as a measure of pre-diabetes suitable for application to large-scale screening studies and to individualized preventive strategies in patients at risk for development of diabetes. This new approach is based on the known alterations in the mix of whole-body fuel utilization that occurs during progression from normal glucose tolerance to impaired glucose tolerance to diabetes. It involves administration of a standard oral glucose tolerance test solution that contains, in addition, a small quantity of the non-radioactive (stable isotope) 13C6-glucose, followed by measurement of breath 13CO2 isotope enrichment. During Phase-I of this project, we have established the proof-of-concept and feasibility of this approach. We have demonstrated that the correlation of the said method with the common indices of insulin resistance possesses similar statistical strength compared with those published for these indices and the currently accepted gold standard, i.e. the glucose-clamp. We have also demonstrated that inter-individual reproducibility of the breath test as a measure of IGT is acceptably low and its correlation with OGTT sufficiently high to permit its development as a non-invasive test of IGT. During Phase-II, we will conduct a number of clinical investigations to: 1) evaluate the intra- and inter-individual variability of our method compared to the glucose-clamp, the three common indices (HOMA-IR, QUICKI, and WBISI), and the standard OGTT; and 2) to evaluate the correlation between our proposed breath test, the glucose-clamp, common indices, and OGTT in individuals whose glycemia ranges from normal glucose tolerance (NGT) to impaired glucose tolerance (IGT) to diabetes and whose body mass index (BMI) covers the range from lean to obese. We anticipate that successful completion of the Phase-II research will lead to the development of a routine method for assessment of insulin resistance and a non-invasive test of IGT for application to screening and individualized preventive studies. After successful completion of Phase-II research and with non-SBIR funding, we will establish a central facility to produce and market appropriate "test kit(s)" along with the necessary analytical expertise - making the method available to all interested parties for clinical or research purposes. PUBLIC HEALTH RELEVANCE: Insulin resistance and impaired glucose tolerance are early manifestations of serious chronic disorders of major concern to public health: diabetes, chronic heart disease, obesity, hypertension, etc. Their early recognition is important for preventive purposes. Currently, the "Gold Standard" for assessing insulin resistance is the so-called glucose-clamp, which is not suitable for general-purpose clinical management of patients. The surrogate methods available currently, the so-called Common indices show large inter- individual variability's for any given value of their corresponding glucose-clamp and, thus, are not suitable for individualized preventive purposes. During Phase-I of this SBIR program, we have demonstrated that a non- invasive Breath Test has the potential to be a suitable surrogate test for the glucose-clamp and as a non- invasive measure of impaired glucose tolerance (pre-diabetes). During Phase-II, we propose to develop this test and to demonstrate its high linear correlation with both the glucose-clamp and oral glucose tolerance test.
描述(由申请人提供):该基金的总体目标是开发一种非侵入性方法,用于评估胰岛素抵抗和糖耐量受损(IGT),作为糖尿病前期的一种衡量标准,适用于大规模筛查研究和糖尿病风险患者的个性化预防策略。这种新的方法是基于已知的改变,在混合的全身燃料利用发生在从正常的葡萄糖耐量受损的葡萄糖耐量糖尿病的进展。它涉及给予标准口服葡萄糖耐量试验溶液,该溶液另外含有少量非放射性(稳定同位素)13 C6-葡萄糖,然后测量呼吸13 CO2同位素富集。在该项目的第一阶段,我们已经建立了这种方法的概念验证和可行性。我们已经证明,所述方法与胰岛素抵抗的常见指标的相关性与这些指标和目前公认的金标准(即葡萄糖钳夹)的相关性相比具有相似的统计强度。我们还证明,个体间的重复性的呼吸试验作为IGT的措施是可以接受的低,其与OGTT的相关性足够高,允许其发展为一个非侵入性的测试IGT。在第二阶段,我们将进行一些临床研究,以:1)评价我们的方法与葡萄糖钳夹法相比的个体内和个体间变异性,(HOMA-IR、QUICKI和WBISI)和标准OGTT;和2)评估我们提出的呼吸试验、葡萄糖钳夹、常见指标和OGTT,其糖耐量范围从正常葡萄糖耐量(NGT)到受损葡萄糖耐量(IGT)到糖尿病,并且其体重指数(BMI)涵盖从瘦到肥胖的范围。我们预计,第二阶段研究的成功完成将导致开发一个常规的方法来评估胰岛素抵抗和IGT的非侵入性测试应用于筛选和个性化的预防性研究。在成功完成第二阶段研究并获得非SBIR资助后,我们将建立一个中心设施,生产和销售适当的“检测试剂盒”沿着必要的分析专业知识-使该方法可供所有感兴趣的各方用于临床或研究目的。公共卫生关系:胰岛素抵抗和葡萄糖耐量受损是公共卫生主要关注的严重慢性疾病的早期表现:糖尿病、慢性心脏病、肥胖症、高血压等。目前,用于评估胰岛素抵抗的“金标准”是所谓的葡萄糖钳夹,其不适合用于患者的通用临床管理。目前可用的替代方法,即所谓的共同指数,对于其相应葡萄糖钳夹的任何给定值,显示出较大的个体间变异性,因此不适合个体化预防目的。在该SBIR项目的I期期间,我们已经证明,无创呼吸测试有可能成为葡萄糖钳夹的合适替代测试,并作为葡萄糖耐量受损(糖尿病前期)的无创测量。在第二阶段,我们建议开发该试验,并证明其与葡萄糖钳夹和口服葡萄糖耐量试验的高度线性相关性。

项目成果

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MORTEZA JANGHORBANI其他文献

MORTEZA JANGHORBANI的其他文献

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{{ truncateString('MORTEZA JANGHORBANI', 18)}}的其他基金

A Non-Invasive Surrogate Test of OGTT to Screen for Pre-diabetes
用于筛查糖尿病前期的无创替代测试 OGTT
  • 批准号:
    7479062
  • 财政年份:
    2008
  • 资助金额:
    $ 29.53万
  • 项目类别:
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
癌症患者骨骼肌损失的无创评估
  • 批准号:
    8502434
  • 财政年份:
    2008
  • 资助金额:
    $ 29.53万
  • 项目类别:
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
癌症患者骨骼肌损失的无创评估
  • 批准号:
    8688746
  • 财政年份:
    2008
  • 资助金额:
    $ 29.53万
  • 项目类别:
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
癌症患者骨骼肌损失的无创评估
  • 批准号:
    8314779
  • 财政年份:
    2008
  • 资助金额:
    $ 29.53万
  • 项目类别:
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
癌症患者骨骼肌损失的无创评估
  • 批准号:
    7385203
  • 财政年份:
    2008
  • 资助金额:
    $ 29.53万
  • 项目类别:
Long-term Iron Needs of Renal Transplant Recipients
肾移植受者的长期铁需求
  • 批准号:
    6932134
  • 财政年份:
    2005
  • 资助金额:
    $ 29.53万
  • 项目类别:
A Test of Iron Malabsorption in Patients with IDA
IDA 患者铁吸收不良的测试
  • 批准号:
    6879868
  • 财政年份:
    2005
  • 资助金额:
    $ 29.53万
  • 项目类别:
Non-invasive Assessment of Insulin Resistance
胰岛素抵抗的无创评估
  • 批准号:
    6989383
  • 财政年份:
    2005
  • 资助金额:
    $ 29.53万
  • 项目类别:
Effective Oral Iron Supplement for Pre-dialysis Patients
针对透析前患者的有效口服铁补充剂
  • 批准号:
    6582011
  • 财政年份:
    2003
  • 资助金额:
    $ 29.53万
  • 项目类别:
A STRATEGY TO PREVENT IRON OVERLOAD IN HEMOCHROMATOSIS
预防血色病铁过量的策略
  • 批准号:
    6074646
  • 财政年份:
    2000
  • 资助金额:
    $ 29.53万
  • 项目类别:

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