NCT07318207招募中不适用
A Pragmatic Clinical Trial of Time-restricted Eating in the University of Kentucky Barnstable Brown Diabetes Center
Justin (Matt) Thomas1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2026年7月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c
研究概览
简要总结
This is a single-arm pragmatic clinical trial of time-restricted eating in patients with type 2 diabetes. Patients will be recruited from the University of Kentucky Barnstable Brown Diabetes Center. Subjects will participate in a 10-hour time-restricted eating intervention for 1-year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 Diabetes
排除标准
- •Pregnant or breastfeeding
- •Diagnosed eating disorder
- •Night shift worker
- •Taking drugs which induce hypoglycemia
- •Unable or unwilling to participate in the time-restricted eating intervention
研究组 & 干预措施
Time-restricted eating
Experimental
Subjects in this group will consume all daily calories within a 10-h window during the day for 1-year.
干预措施: Time-restricted eating (Behavioral)
结局指标
主要结局
Change in Hemoglobin A1c
时间窗: At least 2 timepoints between baseline and 1 year. Since labs will depend on clinic visits, exact timeframe will vary.
HbA1c data will be gathered from patient charts from routine labs collected during clinic visits.
次要结局
- Change in Pittsburgh Sleep Quality Index(Baseline, 6 months, and 1 year)
- Change in Short Form-36 Quality of Life questionnaire scores(Baseline, 6 months, and 1 year)
研究者
Justin (Matt) Thomas
Principal Investigator
University of Kentucky
研究点 (1)
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