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临床试验/NCT06848647
NCT06848647招募中不适用

Treatment of Sleep Apnea to Improve Metabolic Health - a Novel Approach to Unanswered Questions

Uppsala University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Homeostatic model assessment for insulin resistance (HOMA-IR)

研究概览

简要总结

Diabetes and prediabetes prevail among obstructive sleep apnea (OSA) patients. OSA and short sleep both detrimentally affect glycemic control regardless of obesity. With 1 in 10 adults having diabetes, 1 in 10 with prediabetes, and an estimated 600,000 affected by OSA in Sweden, attaining glycemic control is crucial. Though continuous positive airway pressure (CPAP) is the most effective treatment for OSA, its application lacks personalization, ignoring factors like comorbidities and sleep duration. Key unanswered questions regarding CPAP's impact on glycemic control include: 1) Does high CPAP adherence optimize glycemic control? 2) Should short sleep be addressed alongside OSA treatment for glycemic control? 3) Does long-term diabetes hinder CPAP's glycemic control efficacy? The purpose of this project is to enable precision health in CPAP treatment and producing a personalized treatment model for achieving glycemic control in patients with OSA, treated with CPAP. Taking advantage of a large unique patient cohort (600 patients followed over 18 months) with extensive and objective measures on CPAP adherence, OSA reduction, sleep duration, as well as information on comorbidities, anthropometric, lifestyle data, and a wide range of biomarkers related to glycemic control. This comprehensive approach and in-depth analysis will address these questions and generate a personalized treatment strategy for glycemic control in CPAP-treated OSA patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Patients diagnosed with obstructive sleep apnea
  • •Planned for CPAP treatment
  • •18 years and above

排除标准

  • •Patient not wanting to participate in study
  • •Non-Swedish speaking
  • •Judged by physician as non-fit for study participation

结局指标

主要结局

Homeostatic model assessment for insulin resistance (HOMA-IR)

时间窗: From enrollment to the end of treatment at 12 months

Clinical marker: HOMA-IR calculated from blood glucose and serum insuling

Glycated hemoglobin (HbA1c)

时间窗: From enrollment to the end of treatment at 12 months

Clinical maker: glycated hemoglobin (HbA1c) in % and mmol/mol

Blood glucose

时间窗: From enrollment to the end of treatment at 12 months

Clinical marker: blood glucose in mmol/L

Serum insulin

时间窗: From enrollment to the end of treatment at 12 months

Clinical marker: serum insulin in mU/L

Plasma triglycerides

时间窗: From enrollment to the end of treatment at 12 months

Clinical marker: Triglycerides in mg/dL

Plasma cholesterol

时间窗: From enrollment to the end of treatment at 12 months

Clinical marker: plasma cholesterol in mg/dL

HDL-cholesterol

时间窗: From enrollment to the end of treatment at 12 months

Clinial marker: high-density lipoprotein (HDL) cholesterol in mg/dL

LDL-cholesterol

时间窗: From enrollment to the end of treatment at 12 months

Clinical marker: low-density lipoprotein (LDL) cholesterol in mg/dL

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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