Time Restricted Eating for the Treatment of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in percent body weight
研究概览
简要总结
Innovative lifestyle strategies to treat type 2 diabetes (T2DM) are critically needed. At present, daily calorie restriction (CR) is the main diet prescribed to patients with T2DM for weight loss. However, many patients find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day.
In light of these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE is effective for weight loss and improved glycemic control in patients with obesity and prediabetes. However no long-term randomized controlled trial has examined whether TRE is safe and effective for patients with obesity and T2DM.
This study is a 6-month randomized, controlled trial that aims to compare the effects of TRE (eating all food between 12:00 pm to 8:00 pm, without calorie counting), versus CR (25% energy restriction daily), and a control group eating over a period of 10 or more hours per day, on change in body weight (%), glycemic control, and cardiometabolic risk factors, in adults with obesity and T2DM.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •BMI between 30 and 50 kg/m2
- •Previously diagnosed with type 2 diabetes
- •HbA1c between 6.5 and 11%
- •Sedentary or lightly active
排除标准
- •HbA1c below 6.5 or greater than 11%
- •Have a history of cardiovascular disease
- •History of eating disorders (anorexia, bulimia, or binge eating disorder)
- •Not weight stable for 3 months prior to the beginning of study (weight gain or loss > 4%)
- •Eating within less than a 10 hour window at baseline
- •Perimenopausal (menses does not appear every 27-32d)
- •Pregnant, or trying to become pregnant
- •Night shift workers
结局指标
主要结局
Change in percent body weight
时间窗: Measured at baseline and month 6
Measured by an electronic scale
次要结局
- Change in HbA1c(Measured at baseline and month 6)
- Change fasting glucose(Measured at baseline and month 6)
- Change fasting insulin(Measured at baseline and month 6)
- Change in Insulin sensitivity(Measured at baseline and month 6)
- Change in insulin resistance(Measured at baseline and month 6)
- Change in absolute body weight(Measured at baseline and month 6)
- Change in total time in euglycemic range(Measured at baseline and month 6)
- Change in mean glucose level(Measured at baseline and month 6)
- Change in standard deviation of glucose level(Measured at baseline and month 6)
- Change in plasma lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides)(Measured at baseline and month 6)
- Change in systolic and diastolic blood pressure(Measured at baseline and month 6)
- Change in waist circumference(Measured at baseline and month 6)
- Change in body mass index (BMI)(Measured at baseline and month 6)
- Change in insomnia severity(Measured at baseline and month 6)
- Change in risk of sleep apnea(Measured at baseline and month 6)
- Change in fat mass, lean mass, visceral fat mass(Measured at baseline and month 6)
- Adverse events(Measured weekly from baseline to month 6)
- Change in heart rate(Measured at baseline and month 6)
- Change in energy and nutrient intake(Measured at baseline and month 6)
- Change in dietary adherence(Measured at baseline, month 3, and month 6)
- Change in physical activity (steps/d)(Measured at baseline and month 6)
- Change in medication effect score (MES)(Measured at baseline and month 6)
- Change in sleep quality(Measured at baseline and month 6)
研究者
Krista Varady
Professor of Nutrition
University of Illinois at Chicago