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The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes (RaSlo-19)

2020年6月24日 更新者:Steno Diabetes Center Copenhagen
In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential. Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production. Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response. However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings. Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes. In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits. On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon. The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase. This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose. We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.

研究概览

研究类型

介入性

注册 (实际的)

10

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

      • Gentofte、丹麦、2820
        • Steno Diabetes Center Copenhagen

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 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18-70 years
  • Duration of Type 1 Diabetes ≥ 3 years
  • Insulin pump use > 6 months

Exclusion Criteria:

  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
  • Allergy or intolerance to lactose or GlucaGen (Novo Nordisk, Bagsværd, DK)
  • Use of medications that are known to cause QT interval prolongation
  • Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • Females who have different basal insulin pattern depending on their menstrual cycle
  • Inability to understand the individual information and to give informed consent
  • Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Rapid-Slow
This arm will begin with intervention "rapid" (rapid rate of fall in plasma glucose) for the first study visit and proceed to intervention "slow" (slow rate of fall in plasma glucose) for the second study visit.
Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
实验性的:Slow-Rapid
This arm will begin with intervention "slow" (slow rate of fall in plasma glucose) for the first study visit and proceed to intervention "rapid" (rapid rate of fall in plasma glucose) for the second study visit.
Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Positive incremental area under the glucose curve (PI-AUC) (using the plasma glucose concentration before glucagon administration as basal level)
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration

次要结果测量

结果测量
大体时间
Total area under the glucose curve (AUC)
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Peak plasma glucose
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Incremental plasma glucose peak
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Time-to-peak plasma glucose
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Plasma glucose level
大体时间:120 minutes after glucagon administration
120 minutes after glucagon administration
Duration of plasma glucose above 4.0 mmol/l
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Duration of plasma glucose above baseline
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Number of subjects who, after reaching a plasma glucose value > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-10 mmol/l
大体时间:throughout phase 4 (until 120 minutes after glucagon administration)
throughout phase 4 (until 120 minutes after glucagon administration)
Number of subjects who, after reaching a PG > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-7.8 mmol/l
大体时间:throughout phase 4 (until 120 minutes after glucagon administration)
throughout phase 4 (until 120 minutes after glucagon administration)
Time from glucagon administration to reaching a plasma glucose level > 3,9 mmol/l
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Duration of a plasma glucose level in the range of 3.9-10 mmol/l
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Duration of a plasma glucose level in the range of 3.9-7.8 mmol/l
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Change in insulin levels (measured as area under the curve)
大体时间:0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Change in insulin levels (measured as peak change)
大体时间:from baseline to 120 minutes after glucagon administration
from baseline to 120 minutes after glucagon administration
Change in glucagon levels (measured as area under the curve)
大体时间:0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Change in glucagon levels (measured as peak change)
大体时间:0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Average changes in Edinburgh Hypoglycemia Scale
大体时间:measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
Average change in visual analogue scale score for nausea, headache, stomach ache and palpitations
大体时间:measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
Number of subjects experiencing vomiting
大体时间:from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration

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。

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 (实际的)

2019年9月12日

初级完成 (实际的)

2020年1月15日

研究完成 (实际的)

2020年1月15日

研究注册日期

首次提交

2019年9月11日

首先提交符合 QC 标准的

2019年9月20日

首次发布 (实际的)

2019年9月23日

研究记录更新

最后更新发布 (实际的)

2020年6月25日

上次提交的符合 QC 标准的更新

2020年6月24日

最后验证

2020年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 共享支持信息类型

  • 研究协议

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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