Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Despite advancements in care, most adolescents with T1D have higher BMI and significantly higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2. Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian misalignment, which will allow for identification of new mechanisms that can be directly translated into future intervention and prevention trials. The goal of the current study is to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative methodology will be used to identify barriers and facilitators to healthy sleep in adolescents with T1D.
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
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •attending high school
- •diagnosis of type 1 diabetes >1 year
排除标准
- •current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on sleep disorders screening measures
- •regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin, other sleep aids)
- •HbA1c ≥11 or >14% for the previous 2+ measurements
- •IQ<70 or severe mental illness
结局指标
主要结局
HbA1c
时间窗: at 60 days
HbA1c
glycemic variability
时间窗: at 2 weeks
CGM glucose SD
BMI
时间窗: at study entry (baseline)
body mass index
insulin sensitivity from hyperinsulinemic euglycemic clamp
时间窗: at study entry (baseline)
Si
次要结局
未报告次要终点