The Role of Small Intestinal Endocrine Cells in Type 2 Diabetic Hyperglucagonemia (T2DM-PC1-2)
2015年6月25日 更新者:Filip Krag Knop、University Hospital, Gentofte, Copenhagen
Exspression of Prohormone Convertase 1 and 2 in Small Intestinal Endocrine Mucosa Cells in Patients With Type 2 Diabetes
The purpose of this study is to determine whether excessive secretion of glucagon in type 2 diabetes originates from the pancreatic alpha-cells or endocrine cells in the mucosa of the small intestinal.
研究概览
详细说明
Hyperglucagonemia contributes significantly to the hyperglycemia characterizing patients with Type 2 diabetes.
Fasting hyperglucagonemia induces hepatic glucose release resulting in elevated fasting levels of plasma glucose.
Furthermore, lack of postprandial suppression of glucagon secretion - exchanged for a paradoxical postprandial hypersecretion of glucagon - results in increased levels of postprandial plasma glucose.
Additionally, type 2 diabetes is characterized by decreased postprandial responses of the insulinotropic (and glucagonostatic) peptide hormone glucagon-like peptide-1 (GLP-1).
Recent studies from our group suggest that the intestines are involved in the diminshed suppression of glucagon following ingestion of nutrients.
Thus, suppression of glucagon during oral glucose ingestion diminishes and reverses to stimulation while suppression during intravenous administered glucose sustains along with development of glucose intolerance.
In the small intestines mucosal endocrine L-cells secrete GLP-1, which is processed from its precursor, proglucagon, by prohormone convertase 1 (PC1).
In the pancreatic alpha-cells proglucagon is processed to glucagon via prohormone convertase 2 (PC2).
We plan to examine biopsies from the mucosa of the small intestines from patients with type 2 diabetes and from healthy subjects for glucagon production.
Furthermore, the volunteers will be subjected to a standard meal test in order to correlate the gene expression studies with the level of postprandial hyperglucagonemia of the subjects.
研究类型
观察性的
注册 (实际的)
20
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Copenhagen County
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Hellerup、Copenhagen County、丹麦、2900
- Department of Internal Medicine F' laboratory
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
35年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with type 2 diabetes
描述
Inclusion Criteria:
- Diagnosed with type 2 diabetes for at least 3 months
- Normal hemoglobin
- Informed consent
Exclusion Criteria:
- Liver disease (ALAT/ASAT > 2 x normal range)
- Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuriu)
- Treatment with medication that can not be stopped for12 hours
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
2个
健康受试者
|
Double-balloon enteroscopy allows for the entire gastrointestinal tract to be visualized in real time.
The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is also fitted with a balloon.
The procedure is usually done with the use of conscious sedation.
The enteroscope and overtube are inserted through the mouth and passed in conventional fashion (that is, as with gastroscopy) into the small bowel.
Following this, the endoscope is advanced a small distance in front of the overtube and the balloon at the end is inflated.
Using the assistance of friction at the interface of the enteroscope and intestinal wall, the small bowel is accordioned back to the overtube.
The overtube balloon is then deployed, and the enteroscope balloon is deflated.
The process is then continued until the entire small bowel is visualized.
Double-balloon enteroscopy allows for the sampling or biopsying of small bowel mucosa.
Liquid meal consisting of 100 g "Ny NAN" dissolved in 300 ml water (ca.
5000 kJ) to be ingested over 5 minutes.
Blood will be sampled for 4 hours following ingestion.
Samples are centrifuges and plasma will be analysed for glucagon, GLP-1, GIP, insulin and C-peptide concentrations.
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1
Patients with type 2 diabetes
|
Double-balloon enteroscopy allows for the entire gastrointestinal tract to be visualized in real time.
The technique involves the use of a balloon at the end of a special enteroscope camera and an overtube, which is also fitted with a balloon.
The procedure is usually done with the use of conscious sedation.
The enteroscope and overtube are inserted through the mouth and passed in conventional fashion (that is, as with gastroscopy) into the small bowel.
Following this, the endoscope is advanced a small distance in front of the overtube and the balloon at the end is inflated.
Using the assistance of friction at the interface of the enteroscope and intestinal wall, the small bowel is accordioned back to the overtube.
The overtube balloon is then deployed, and the enteroscope balloon is deflated.
The process is then continued until the entire small bowel is visualized.
Double-balloon enteroscopy allows for the sampling or biopsying of small bowel mucosa.
Liquid meal consisting of 100 g "Ny NAN" dissolved in 300 ml water (ca.
5000 kJ) to be ingested over 5 minutes.
Blood will be sampled for 4 hours following ingestion.
Samples are centrifuges and plasma will be analysed for glucagon, GLP-1, GIP, insulin and C-peptide concentrations.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Filip K Knop, MD PhD、Department of Internal Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年3月1日
初级完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2008年3月12日
首先提交符合 QC 标准的
2008年3月12日
首次发布 (估计)
2008年3月20日
研究记录更新
最后更新发布 (估计)
2015年6月26日
上次提交的符合 QC 标准的更新
2015年6月25日
最后验证
2015年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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