NCT04841837Unknown不适用
Effect of Time-restricted Eating on Blood Glucose and Behavior in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Mean blood glucose
研究概览
简要总结
Diet management could improve blood and weight control in patients with diabetes mellitus. Time-restricted feeding is a novel dietary tool that limits time of energy intake without altering diet quality or quantity. This study aims to assess the effect of 10-hour time-restricted feeding on metabolism and behavior in patients with type 2 diabetes mellitus.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus
- •HbA1c 7.0% to 8.5%
- •BMI ≥ 24 kg/m2
- •Time of energy intake ≥ 12 hours per day, ≥ 4 days per week
- •Ability to use smart phone and app, to follow study protocol
- •Sign informed consent
排除标准
- •Use insulin, long-acting insulin secretagogues, GLP-1 receptor agonist, DPP-4 inhibitor, SGLT-2 inhibitor
- •Suffer from disease influence eating: mental disease, subtotal gastrectomy, inflammatory bowel disease, uncontrolled thyroid disease
- •Work state affect eating time: constant night duty, constant long-haul international travel
- •Severe disease: severe cardiovascular and cerebrovascular disease, uncontrolled arrhythmia, heart failure, acute and chronic renal dysfunction, liver cirrhosis, malignancy, anemia
- •Suffered from infectious disease: pulmonary tuberculosis, AIDS
- •Body weight change ≥ 5 kg in the past 3 months
- •Hospitalized in the past 3 months
- •Used antibiotics for ≥ 3 days in the past 3 months
- •Diagnosed with type 1 diabetes mellitus
- •Pregnancy, lactating
- •Participating in other clinical trials in the past 1 months
研究组 & 干预措施
Time-restricted feeding
Experimental
Restrict all calorie intake within a self-selected 10-hours window for 12 weeks, without necessarily altering diet quality and quantity
干预措施: Time-restricted feeding (Behavioral)
结局指标
主要结局
Mean blood glucose
时间窗: through study completion, an average of 12 weeks
HbA1c
时间窗: through study completion, an average of 12 weeks
Time in range
时间窗: through study completion, an average of 12 weeks
次要结局
- Compliance of time-restricted feeding(through study completion, an average of 12 weeks)
- Adverse event(through study completion, an average of 12 weeks)
- type and proportion of intestinal flora(through study completion, an average of 12 weeks)
- Body weight (kg)(through study completion, an average of 12 weeks)
- Body composition (fat and muscle mass)(through study completion, an average of 12 weeks)
研究者
研究点 (1)
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