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临床试验/NCT02871180
NCT02871180已完成不适用

A Late Night Snack May be Necessary to Prevent Nocturnal Hyperglycemia in Type 1-diabetic Patients Using Insulin Glargine (LANTUS)

Diabeteszentrum Bad Lauterberg im Harz2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Hypoglycemia

研究概览

简要总结

Twenty patient with Type 1 diabetes, using insulin glargine as basal insulin, participated in a prospective, controlled crossover trial comparing blood glucose profiles over two 24 h periods with and without a late night snack (a slice of rye bread, 20 g carbohydrates, at 10 p.m.), in randomized order. The main endpoint was the number of hypoglycemic episodes with a confirmed laboratory blood glucose ≤ 50 mg/dl between 10 p.m. and 8 p.m. the following day. Secondary endpoint was the blood glucose profile during this period.

详细描述

The order of studies (with and without a late night snack) was determined by randomization. Study-related procedures started at 6 p.m. (standard blood glucose profiles with determinations at 6, 8, and 10 p.m, at midnight, at 2, 4, 6:45, 8:45 a.m., and at noon and 2, 6, and 8 p.m. of the following day). At 10 p.m. a late night snack (one slice of whole meal rye bread containing approximately 20 g of carbohydrate) was eaten or no nutrients were consumed, as determined by the randomization protocol. After one day without study-related activities, the study was repeated with the complementary protocol (crossover design). Patients were instructed to use fast-acting insulin to correct hyperglycemia three times per day (before major meals) or to take in additional carbohydrate when symptomatic or chemical hypoglycemia was noted. They were asked not to perform strenuous exercise beyond their normal daily activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 1 diabetes
  • Basal insulin substitution with insulin glargine at least 3 month

排除标准

  • Severe disorders
  • Severe and clinical significant gastroparesis
  • History of pancreatitis or pancreatic cancer
  • Severe Liver disorder (liver enzymes > three times upper normal limit)
  • Pregnancy
  • Drug- or alcohol abuse

结局指标

主要结局

Hypoglycemia

时间窗: 26 hours

Hypoglycemia with a plasma glucose ≤ 50 mg/dl as determined with a standardized laboratory method

次要结局

  • Blood glucose profile(26 hours)

研究者

发起方
Diabeteszentrum Bad Lauterberg im Harz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael A. Nauck

Prof. Dr. med. Michael A. Nauck

Diabeteszentrum Bad Lauterberg im Harz

研究点 (2)

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