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临床试验/NCT00529048
NCT00529048已完成不适用

Quantification of the Incretin Effect in Healthy Subjects and Patients With Type 2 Diabetes Using Increasing Amounts of Oral Glucose Challenges

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Progress in Incretin effect in patients with T2DM compared with healthy subjects

研究概览

简要总结

Patients with T2DM lac a sufficient incretin response after oral glucose intake. It has only been tested using 50g of glucose. We don't know if patients with T2DM are capable of regulating the incretin effect like healthy people in responds to different amounts of glucose intake.

The aim of the present study is to quantify the incretin effect in healthy subjects and in patients with T2DM during increasing amounts of oral glucose challenges. The proposed studies will answer important questions on the mechanisms underlying T2DM and be of importance in relation to future preventive- and treatment strategies.

详细描述

The impaired incretin effect in patients with type 2 diabetes mellitus (T2DM) has previously only been evaluated using a glucose load of 50 g, and it is uncertain whether patients with T2DM are capable of regulating their incretin effect equivalent to healthy subjects. Furthermore, it is of great interest to quantify the secretion of GIP and GLP-1 during increasing glucose loads in both patients with T2DM and in healthy subjects in order to evaluate whether an increased secretion of one or both of the two incretin hormones contributes to the regulation of the incretin effect.

The aim of the present study is to quantify the incretin effect in healthy subjects and in patients with T2DM during increasing amounts of oral glucose challenges and corresponding isoglycemic iv glucose challenges. The proposed studies will answer important questions on the pathophysiology underlying T2DM and be of importance in relation to future preventive- and treatment strategies.

Eight patients with T2DM and 8 matched healthy subjects will be evaluated with oral glucose tolerance tests (OGTT) using increasing glucose loads (25, 50 and 100 g glucose) and isoglycemic iv glucose tolerance tests imitating the glucose concentrations as obtained during the oral glucose loads. The results will describe the regulation of the incretin effect in patients with T2DM and, thereby, contribute to the clarification of the pathophysiology of the postprandial hyperglycemia characterizing these patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

  • Caucasians with T2DM according to WHO's criteria
  • Normal Hemoglobin
  • Agree to participate (orally and in writing)
  • HbA1c: 6.5-9 %
  • BMI: 23-35 kg/m2

排除标准

  • Liver disease (ALAT > 2 x normal level)
  • Diabetic nephropathy (s-creatinin > 130 µM or albuminuria)
  • Diabetic neuropathy (anamnestic)
  • Proliferative diabetic retinopathy (anamnestic)
  • Medical treatment witch cannot be stopped for 12 hours
  • Pregnancy or breastfeed
  • Treatment with Insulin or glitazones
  • Inclusion Criteria: Control group
  • Caucasians
  • Normal oral glucose tolerance according to WHO's criteria
  • Normal Hemoglobin
  • Agree to participate (orally and in writing)
  • BMI: 23-35 kg/m2
  • Exclusion Criteria: Control group
  • Liver disease (ALAT > 2 x normal level)
  • Impaired function of the kidney (s-creatinin > 130 µM or albuminuria)
  • Directly related til to someone suffering from diabetes mellitus
  • Medical treatment witch cannot be stopped for 12 hours
  • Pregnancy or breastfeed

结局指标

主要结局

Progress in Incretin effect in patients with T2DM compared with healthy subjects

时间窗: 4 hours

次要结局

  • GIP and GLP-1 responscurvs(4 hours)

研究者

申办方类型
Other

研究点 (1)

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