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临床试验/NCT00843791
NCT00843791终止不适用

Ghrelin Regulation and Structure: Effect of Thiazolidinedione Therapy on Ghrelin

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Total and Active Ghrelin Levels

研究概览

简要总结

The purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.

详细描述

Insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. Improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 80, weight stable for at least 3 months
  • At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:
  • fasting plasma glucose level of 100- 125mg/dL or
  • plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load

排除标准

  • Actively losing weight
  • Alcohol consumption > 2 drinks/day
  • Prescription drug use
  • Recreational drug use
  • Type 2 Diabetes
  • Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone

研究组 & 干预措施

Placebo

Placebo Comparator

Treatment with placebo for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.

干预措施: placebo (Drug)

pioglitizone

Active Comparator

Treatment with pioglitazone for 3 months before hyperinsulinemic-euglycemic clamp, control diet with blood sampling and spectroscopy.

干预措施: pioglitazone (Drug)

结局指标

主要结局

Total and Active Ghrelin Levels

时间窗: 0 and 3 months

The primary outcome of this study will be the comparison of ghrelin suppressibility (total and acylated) in response to meals obese subjects before and after 3-months therapy with a thiazolidinedione.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Purnell

Prinicipal Investigator

Oregon Health and Science University

研究点 (1)

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