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临床试验/NCT02513641
NCT02513641已完成不适用

Effect of 2-Week Nightly Moderate Hypoxia on Oral Glucose Tolerance in Individuals With Type 2 Diabetes

Pennington Biomedical Research Center3 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年12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
8
试验地点
3
主要终点
Insulin Sensitivity

研究概览

简要总结

The purpose of this study is to determine if 2 weeks of nightly exposure (7-12 hours per night) to moderate hypoxia (~2,400 meters or 7,500 feet) improves glucose metabolism in people with type 2 diabetes.

详细描述

Exposure to hypoxia has been advocated as a possible therapeutic aid against obesity. Indeed, our laboratory has provided the first evidence that intermittent, nightly exposure to moderate hypoxia is beneficial in improving insulin sensitivity in healthy obese patients and, therefore, lowers the risk of developing type 2 diabetes. Benefits included reduced fasting glucose levels and improved whole-body (skeletal muscle) and hepatic insulin sensitivity. Whether such intermittent hypoxia improves glucose metabolism in people with type 2 diabetes is unknown.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(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

Insulin Sensitivity

时间窗: Baseline and Post-Moderate Hypoxia (14 days)

Insulin sensitivity was determined using an oral glucose tolerance test. Insulin sensitivity was estimated using the whole-body insulin sensitivity index (WBISI), also known as the Matsuda Index (unitless): WBISI = 10,000 / \[square root of (Glu0 x Ins0) x (mean glucose x mean insulin during an oral glucose tolerance test)\] where Glu0 and Ins0 denote baseline glucose and insulin concentrations.

次要结局

  • Insulin Secretion(Baseline and Post-Moderate Hypoxia (14 days))
  • Beta-cell Function(Baseline and Post-Moderate Hypoxia (14 days))
  • 2-hour Glucose Area-under-the-curve(0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days))
  • 2-hour Insulin Area-under-the-curve Via Oral Glucose Tolerance Test(0, 0.5, 1, 1.5, and 2 hours at Baseline and Post-Moderate Hypoxia (14 days))

研究者

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

Eric Ravussin

Principal Investigator

Pennington Biomedical Research Center

研究点 (3)

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