Interfacing Adiposity, Sleep Apnea, and Insulin Resistance
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
- 是
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
pioglitazone 45 mg, oral, daily
干预措施: Pioglitazone (Drug)
placebo
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
Gerald M Reaven
Professor Emeritus
Stanford University
