Beta Cell Function in (Pre) Type 1 Diabetes
2013年12月27日 更新者:Bart Keymeulen、AZ-VUB
This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.
研究概览
详细说明
This study will establish criteria indicating short-term loss of beta cell mass and therefore accelerated progression towards type 1 diabetes.
These criteria may help to determine the time point and type of prevention may contribute to the composition of homogeneous groups of study subjects (based on residual beta cell mass, homogeneous risk of beta cell destruction during intervention) and may lead to the identification of functional markers that could be used as surrogate endpoints.
This may reduce the number of subjects needed to treat as well as the follow-up time necessary to study significant effects of the test substance.
研究类型
介入性
注册 (预期的)
200
阶段
- 阶段2
- 阶段1
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
-
-
-
Antwerpen、比利时
- Universitair Ziekenhuis Antwerpen
-
Brussels、比利时、1090
- UZ Brussels
-
Gent、比利时、9000
- UZ Gent
-
Leuven、比利时、3000
- UZ Leuven
-
-
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
5年 至 40年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
The following groups of first degree relatives of type1 diabetes patients with normal glucose tolerance during OGTT (5-39 years) will be included after informed consent on the basis of their antibody status (n = 40 per group):
- IA-2A-positives;
- Ab.-positives (positive for at least 2 different Abs. (IAA, GADA and/or ICA) and/or persistently Ab.-positive for 1 of these Abs;
- persistently Ab.-negatives.
- 40 type 1 diabetes patients with the following criteria will be studied: 1) aged 12-39 years; 2) < 4 weeks of insulin treatment; 3) auto-Ab.-positive; 4) polyuria since < 6 months; 5) < 10% weight loss over the last 6 months; 6) informed consent.
Exclusion Criteria:
- Pregnancy or lactation in women
- Use of illicit drugs or overconsumption of alcohol (> 3 beers/day) or history of drug or alcohol abuse
- Being legally incapacitated, having significant emotional problems at the time of the study, or having a history of psychiatric disorders
- Having received antidepressant medications during the last 6 months
- Treatment with immune modulating or diabetogenic medication (such as corticosteroids)
- Presently participating in another clinical study
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the subjects
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
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:FDR of type 1 diabetes patients receiving glucose 20%
First Degree Relatives of diabetes type 1 patient with a high, intermedian or low risk (accoring to the criteria of the protocol), for developing diabetes type 1.
|
maintain glycemia at 180 mg/dL till 150 min.
after start glucose infusion: with a maintenance dose computed at 5- to 10-minute intervals
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The systematic and simultaneous determination of markers of functional beta cell mass and immune status allows stratification according to the stage of the pathogenic process rather than according to a late metabolic consequence of this process
大体时间:48 months
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48 months
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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。
赞助
调查人员
- 首席研究员:katelijn Decochez, MD PhD、UZ Brussels
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
- Decochez K, De Leeuw IH, Keymeulen B, Mathieu C, Rottiers R, Weets I, Vandemeulebroucke E, Truyen I, Kaufman L, Schuit FC, Pipeleers DG, Gorus FK; Belgian Diabetes Registry. IA-2 autoantibodies predict impending type I diabetes in siblings of patients. Diabetologia. 2002 Dec;45(12):1658-66. doi: 10.1007/s00125-002-0949-8. Epub 2002 Nov 12.
- Gorus FK, Goubert P, Semakula C, Vandewalle CL, De Schepper J, Scheen A, Christie MR, Pipeleers DG. IA-2-autoantibodies complement GAD65-autoantibodies in new-onset IDDM patients and help predict impending diabetes in their siblings. The Belgian Diabetes Registry. Diabetologia. 1997 Jan;40(1):95-9. doi: 10.1007/s001250050648.
- Achenbach P, Warncke K, Reiter J, Naserke HE, Williams AJ, Bingley PJ, Bonifacio E, Ziegler AG. Stratification of type 1 diabetes risk on the basis of islet autoantibody characteristics. Diabetes. 2004 Feb;53(2):384-92. doi: 10.2337/diabetes.53.2.384. Erratum In: Diabetes. 2004 Apr;53(4):1175-6.
- Bingley PJ, Gale EA; European Nicotinamide Diabetes Intervention Trial (ENDIT) Group. Progression to type 1 diabetes in islet cell antibody-positive relatives in the European Nicotinamide Diabetes Intervention Trial: the role of additional immune, genetic and metabolic markers of risk. Diabetologia. 2006 May;49(5):881-90. doi: 10.1007/s00125-006-0160-4. Epub 2006 Mar 3.
- Maclaren N, Lan M, Coutant R, Schatz D, Silverstein J, Muir A, Clare-Salzer M, She JX, Malone J, Crockett S, Schwartz S, Quattrin T, DeSilva M, Vander Vegt P, Notkins A, Krischer J. Only multiple autoantibodies to islet cells (ICA), insulin, GAD65, IA-2 and IA-2beta predict immune-mediated (Type 1) diabetes in relatives. J Autoimmun. 1999 Jun;12(4):279-87. doi: 10.1006/jaut.1999.0281.
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
2006年10月1日
初级完成 (预期的)
2014年10月1日
研究完成 (预期的)
2015年10月1日
研究注册日期
首次提交
2008年11月28日
首先提交符合 QC 标准的
2008年11月28日
首次发布 (估计)
2008年12月1日
研究记录更新
最后更新发布 (估计)
2013年12月30日
上次提交的符合 QC 标准的更新
2013年12月27日
最后验证
2013年12月1日
更多信息
与本研究相关的术语
其他研究编号
- KD_BF_01
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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