CLINICAL TRIAL: EFFECTS OF PIOGLITAZONE ON INCRETIN AXIS IN PTS W TYPE 2 DIABETE

临床试验：吡格列酮对 2 型糖尿病 PTS 肠促胰岛素轴的影响

• 批准号: 7952123
• 负责人: RICHARD E PRATLEY
• 金额: $ 3.08万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-03-01 至 2010-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952123
• 关键词: Address; Blood Glucose; Body fat; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; DEXA; Diabetes Mellitus; Diagnosis; Dose; Eating; Fatty acid glycerol esters; Funding; GNAI2 gene; Glucose; Grant; Hormones; Institution; Insulin; Lead; Measurement; Measures; Medicine; Metabolism; Metformin; Needles; Non-Insulin-Dependent Diabetes Mellitus; OGTT; Pancreas; Patients; Pharmaceutical Preparations; Phase; Pioglitazone; Placebos; Randomized; Recruitment Activity; Research; Research Personnel; Resources; Sampling; Scanning; Series; Skin; Source; Tablets; Takeda brand of pioglitazone hydrochloride; Testing; United States National Institutes of Health; Veins; Work; blood glucose regulation; diet and exercise; gastric inhibitory polypeptide receptor; glucagon-like peptide 1; glucose metabolism; improved; incretin hormone; insulin secretion; prevent; response; sugar

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Incretin hormones are hormones produced by the gut in response to food intake. These hormones help the body to control the metabolism of glucose (sugar). In particular, two incretin hormones (GLP-1 and GIP) cause the pancreas to secrete more insulin in response to high blood glucose levels. This helps the body to metabolize the glucose more effectively, lowering blood sugar levels. GLP-1 and GIP do not work as well in patients with type 2 diabetes (T2DM) as in subjects who do not have diabetes. This study tests whether a medicine called pioglitazone (Actos ), which is commonly used to treat T2DM, improves the ability of GIP to increase insulin secretion. To address this question we will recruit patients with T2DM whose diabetes is controlled with either diet and exercise or with metformin (another medicine commonly used to treat T2DM). Subjects will undergo measurement of body fat by DEXA scanning and a series of studies to characterize their metabolism. These studies include an oral glucose tolerance test (a test sometimes used to diagnose diabetes), a mixed-meal challenge (to measure how much GLP-1 and GIP are produced in response to a meal) and measurement of insulin secretion in response to glucose and GIP given through a vein. We will also obtain small samples of fat (from just under the skin of the belly) using a needle to measure levels of the receptor for GIP. Subjects will then be randomly assigned to 12 weeks of treatment with either pioglitazone or matching placebo (an inactive tablet that does not contain medication). The dose of pioglitazone will be increased during the first 4 weeks to the maximum prescribed dose of 45 mg per day. Subjects will be seen every 2-4 weeks during the treatment phase of the study. After 12 weeks of treatment all studies performed at the beginning of the study will be repeated. The pioglitazone treatment will continue until the end of testing, approximately 4 weeks. The results of this study may give us information about why glucose control deteriorates in T2DM. This information might also lead to new ways to prevent or treat T2DM.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 肠促胰岛素激素是肠道响应食物摄入而产生的激素。这些激素帮助身体控制葡萄糖（糖）的代谢。特别是，两种肠促胰岛素激素（GLP-1 和 GIP）会导致胰腺分泌更多胰岛素以应对高血糖水平。这有助于身体更有效地代谢葡萄糖，降低血糖水平。 GLP-1 和 GIP 在 2 型糖尿病 (T2DM) 患者中的作用不如未患有糖尿病的受试者。这项研究测试了一种常用于治疗 T2DM 的药物吡格列酮 (Actos) 是否可以提高 GIP 增加胰岛素分泌的能力。 为了解决这个问题，我们将招募通过饮食和运动或二甲双胍（另一种常用于治疗 T2DM 的药物）控制糖尿病的 T2DM 患者。受试者将通过 DEXA 扫描测量身体脂肪，并进行一系列研究来表征其新陈代谢。这些研究包括口服葡萄糖耐量测试（有时用于诊断糖尿病的测试）、混合膳食挑战（测量餐食后 GLP-1 和 GIP 的产生量）以及通过静脉给予葡萄糖和 GIP 时胰岛素分泌的测量。我们还将使用针获取少量脂肪样本（来自腹部皮肤下方）来测量 GIP 受体的水平。然后，受试者将被随机分配接受 12 周的吡格列酮或匹配安慰剂（一种不含药物的非活性药片）治疗。吡格列酮的剂量将在前 4 周内增加至每天 45 mg 的最大处方剂​​量。在研究的治疗阶段，将每 2-4 周对受试者进行一次检查。治疗 12 周后，将重复研究开始时进行的所有研究。吡格列酮治疗将持续到测试结束，大约 4 周。 这项研究的结果可能为我们提供有关 T2DM 血糖控制恶化的原因的信息。这些信息还可能带来预防或治疗 T2DM 的新方法。