Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms (Bariglykos)
2020年3月30日 更新者:Uppsala University
The main purpose of this project is to further explore the metabolic effects and the mechanisms underlying the improvement in glucose homeostasis following bariatric surgery.
The project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both pre-diabetic as well as diabetic subjects with obesity will be included.
This part of the project focuses on patients with manifest T2D and they will be assigned to surgical and non-surgical intervention, respectively, in a strictly controlled and randomized manner.
研究概览
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
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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Uppsala、瑞典
- Uppsala University, Department of Medical Sciences, Clinical diabetology and metabolism
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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
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Males and females aged 18-60 years
- Type 2 Diabetes Mellitus with duration of no more than 10 years, treated with 0-3 oral anti-diabetic drugs or Glucagon-like peptide-1 (GLP-1) analog.
Exclusion Criteria:
- Pregnant or planning to be pregnant during the study.
- Known or suspected history of significant drug abuse.
- History of alcohol abuse or excessive intake of alcohol as judged by investigator.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator
- Sleep apnea
- Any previous serious cardiovascular event, stroke , acute myocardial infarction.
- Diabetes complications : proliferative retinopathy, maculopathy, chronic renal failure stadium 3 with an Estimated Glomerular Filtration Rate (eGFR) <60, foot ulcers, symptomatic neuropathy
- Medications within 3 months : Insulin, Thiazolidinediones
- Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study and /or for the patients safety
- Judgment by the investigator that the subject should not participate in the study if considers subject unlikely to comply with study procedures, restrictions and requirements.
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
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预:控制组
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其他:Surgery Group
The patients in this group will undergo Laparoscopic Gastric Bypass surgery
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change from Baseline of Glucose Turnover
大体时间:1 month after surgery
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1 month after surgery
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Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
大体时间:1 month after surgery
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1 month after surgery
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Change from Baseline of beta cell function
大体时间:1 month after surgery
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1 month after surgery
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from Baseline of Glucose Turnover
大体时间:6 months after surgery
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6 months after surgery
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Change from Baseline of Glucose Turnover
大体时间:24 months after surgery
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24 months after surgery
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Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
大体时间:6 months after surgery
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6 months after surgery
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Change from Baseline of homeostatic model assessment (HOMA) for insulin resistance
大体时间:24 months after surgery
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24 months after surgery
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Change from Baseline of beta cell function
大体时间:6 months after surgery
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6 months after surgery
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Change from Baseline of beta cell function
大体时间:24 months after surgery
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24 months after surgery
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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。
调查人员
- 首席研究员:Jan Eriksson, Professor、Department of Medical Sciences, Clinical diabetology and metabolism
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
- Almby KE, Katsogiannos P, Pereira MJ, Karlsson FA, Sundbom M, Wiklund U, Kamble PG, Eriksson JW. Time Course of Metabolic, Neuroendocrine, and Adipose Effects During 2 Years of Follow-up After Gastric Bypass in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4049-e4061. doi: 10.1210/clinem/dgab398.
- Katsogiannos P, Randell E, Sundbom M, Rosenblad A, Eriksson JW, Leksell J. Quality of life after gastric bypass surgery in patients with type 2 diabetes: patients' experiences during 2 years of follow-up. Diabetol Metab Syndr. 2020 Oct 12;12:90. doi: 10.1186/s13098-020-00597-1. eCollection 2020.
- Katsogiannos P, Kamble PG, Boersma GJ, Karlsson FA, Lundkvist P, Sundbom M, Pereira MJ, Eriksson JW. Early Changes in Adipose Tissue Morphology, Gene Expression, and Metabolism After RYGB in Patients With Obesity and T2D. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2601-2613. doi: 10.1210/jc.2018-02165.
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
2014年10月1日
初级完成 (实际的)
2019年12月30日
研究完成 (实际的)
2020年2月10日
研究注册日期
首次提交
2016年3月16日
首先提交符合 QC 标准的
2016年3月30日
首次发布 (估计)
2016年4月6日
研究记录更新
最后更新发布 (实际的)
2020年3月31日
上次提交的符合 QC 标准的更新
2020年3月30日
最后验证
2020年3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.