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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 肠降血糖素激素是肠道响应食物摄入量产生的激素。这些激素有助于人体控制葡萄糖（糖）的代谢。特别是，两种泌尿素激素（GLP-1和GIP）会导致胰腺分泌更多的胰岛素，以响应高血糖水平。这有助于人体更有效地代谢葡萄糖，从而降低血糖水平。 GLP-1和GIP在2型糖尿病患者（T2DM）的患者中不如没有糖尿病的受试者。这项研究测试了一种通常用于治疗T2DM的药物（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T2DM患者的糖尿病患者，其糖尿病是通过饮食和运动或二甲双胍控制的（另一种通常用于治疗T2DM的药物）。受试者将通过DEXA扫描对体内脂肪进行测量，并进行一系列研究以表征其新陈代谢。这些研究包括口服葡萄糖耐受性测试（有时用于诊断糖尿病的测试），一种混合​​粉碎挑战（以响应餐食来衡量产生多少GLP-1和GIP），并测量胰岛素分泌，以响应通过静脉给出的葡萄糖和GIP。我们还将使用针头测量GIP的受体水平（从腹部的皮肤下方）获得少量脂肪样本。然后将受试者随机分配给吡格列酮或匹配的安慰剂（不含药物的不活跃的片剂）的12周治疗。吡格列酮的剂量将在最初的4周内增加，每天的规定剂量为45 mg。在研究的治疗阶段，将每2-4周看到受试者。经过12周的治疗后，将重复进行研究开始时进行的所有研究。吡格列酮的治疗将持续到大约4周的测试结束。 这项研究的结果可能会为我们提供有关为什么葡萄糖控制在T2DM中恶化的信息。此信息还可能导致预防或治疗T2DM的新方法。