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临床试验/NCT00432887
NCT00432887已完成早期 1 期

Caffeine and Glucose Regulation

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)0 个研究点目标入组 150 人开始时间: 2004年7月最近更新:
适应症
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
150
主要终点
postprandial glucose and insulin

研究概览

简要总结

This project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have Type 2 diabetes. In our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with type 2 diabetes. On separate study days subjects receive standard meals after taking capsules containing either caffeine or an inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to measure glucose levels during everyday activities on days when subjects receive caffeine or placebo.

These studies do not involve clinical treatment or disease management. However, we hope to learn whether a very popular drug impairs the clinical management of a common disease.

详细描述

Pilot results suggest that caffeine, the most commonly used drug in the world, may interfere with postprandial glucose metabolism by increasing insulin resistance and/or by stimulating hepatic glucose production. This effect could have serious clinical implications for coffee drinkers who have type 2 diabetes. Early results suggest caffeine exaggerates the postprandial hyperglycemia and hyperinsulinemia present in these patients.

The experimental (non-treatment) studies in this project include double-blind placebo-controlled cross-over laboratory tests of glucose tolerance in groups of type 2 diabetic patients and prediabetic volunteers who are coffee drinkers.

The lab studies test the hypothesis that caffeine (vs. placebo) increases postprandial insulin responses and results in a potentiation of glucose responses in the type 2 group.

An ambulatory study examines the effects of caffeine administration on glucose levels during everyday activities in the natural environment. This study uses a double-blind placebo-controlled cross-over design. Ambulatory glucose data are collected with a MiniMed CGMS sensor and recorder worn for 72 hours. Caffeine and placebo are administered on separate days. Average glucose levels and glucose responses to meals are compared across treatment days within subjects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

postprandial glucose and insulin

fasting glucose and insulin

insulin resistance

glucose tolerance

次要结局

  • cortisol
  • norepinephrine
  • epinephrine
  • blood pressure
  • plasma caffeine concentration

研究者

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