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临床试验/NCT02192684
NCT02192684已完成不适用

Interfacing Adiposity, Sleep Apnea, and Insulin Resistance

Stanford University0 个研究点目标入组 45 人开始时间: 2010年9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
已完成
入组人数
45
主要终点
Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo

研究概览

简要总结

Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.

研究设计

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

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy Individuals
  • Age 30-70 years old
  • BMI- 25-40 kg/m2
  • Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography

排除标准

  • Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer.
  • Must not have previously received treatment for OSA, including CPAP.
  • Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity.
  • Pregnancy/lactation is also an exclusion.

研究组 & 干预措施

pioglitazone

Active Comparator

pioglitazone 45 mg, oral, daily

干预措施: Pioglitazone (Drug)

placebo

Placebo Comparator

Placebo, one pill daily

干预措施: placebo (Drug)

结局指标

主要结局

Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo

时间窗: 8 weeks

To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.

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

Gerald M Reaven

Professor Emeritus

Stanford University

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Obesity, Sleep Apnea, and Insulin Resistance | 临床试验