TRE in Type 2 Diabetes Mellitus (See Food Study 3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in Glycemic Measures- HbA1c (12w)
研究概览
简要总结
Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients [BMI:25-45 kg/m2] with metformin-only treated Type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese adults with metformin-only treated type 2 diabetes
- •18-65 years old
- •BMI:25-45 kg/m2
- •HbA1c: 6.5-8.5%
- •Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study
- •Owns a smartphone.
排除标准
- •Active or anticipated pregnancy during the study
- •type 2 diabetes treated with medications other than metformin
- •presence of eating disorders as noted by screening survey.
研究组 & 干预措施
Time restricted eating
daily 8 hour eating window
干预措施: Time restricted eating (Behavioral)
Caloric Restriction
reduction of caloric intake by 15%
干预措施: Caloric reduction (Behavioral)
结局指标
主要结局
Change in Glycemic Measures- HbA1c (12w)
时间窗: 12 weeks
Change in hemoglobin A1c
次要结局
- Intervention Burden (24w)(24 weeks)
- Weight Change (12w)(12 weeks)
- Weight Change (24w)(24 weeks)
- Change in Glycemic Measures- Insulin (12w)(12 weeks)
- Change in Glycemic Measures- Insulin (24w)(24 weeks)
- Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (24w)(24 weeks)
- Change in Glycemic Measures- Homeostatic Model Assessment for Insulin Resistance (12w)(12 weeks)
- Change in Glycemic Measures- HbA1c (24w)(24 weeks)
- Change in Glycemic Measures- Glucose (24w)(24 weeks)
- Change in Glycemic Measures- Glucose (12w)(12 weeks)
- Intervention Burden (12w)(12 weeks)