Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- OhioHealth
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- mean glucose
研究概览
简要总结
In this 3-week interventional study, the investigators hypothesize that therapeutic Time-Restricted Feeding in patients with poorly controlled Type 2 diabetes mellitus (T2DM) can improve their mean glucose or estimated glycated hemoglobin levels with the same dose, or even reduced dose, of antidiabetics.
详细描述
Time-restricted feeding (TRF) has recently gained popularity as a means of reducing body weight and improving glycemia. A recent clinical trial in men who had prediabetes showed that TRF for five weeks significantly reduced fasting insulin concentration and improved the derived oral glucose tolerance test ( OGTT) indexes of beta-cell responsiveness and insulin resistance. However, the effects of TRF have not been studied in patients with poorly controlled Type 2 diabetes mellitus (T2DM). In this 3-week interventional self-controlled clinical trial, the investigators hypothesize that TRF in patients with poorly-controlled T2DM can improve their mean glucose with the same dose/reduced dose of antidiabetics. Potential study subjects will be identified from Endocrinology clinic patients with a diagnosis of poorly controlled type 2 DM (A1c >= 8.0 in the 3 months before enrollment) based on inclusion and exclusion criteria. All study subjects will be in the ad libitum feeding phase for one week, and then will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for the second week. For the third and final week, patients will be returned to the ad libitum feeding phase. The first and third weeks will serve as the control phases, and the second week will be the experimental phase. The mean glucose, serum triglyceride levels, insulin resistance, and body weights will be compared between the two phases. Results of this clinical study may demonstrate a low-cost and practical way of diabetic control.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and < 65 years
- •With the diagnosis of type 2 diabetes
- •A1c >= 8.0 on the most recent test in the 3 months before enrollment
- •Have been on stable antidiabetics in the 3 months before enrollment
- •OhioHealth Patient
排除标准
- •Pregnant or breastfeeding patients
- •Severe hypoglycemic episodes (defined as having low blood glucose levels that requires assistance from another person to treat) in the past 12 months
- •Unable to give informed consent
- •Currently enrolled in another therapeutic study
- •Thyroid dysfunction, as defined by abnormal thyroid function test results within the past 6 months
- •Advanced stage of renal (stage 4 or above) or hepatic (cirrhosis) or respiratory (needs oxygen) or heart failure (NYHA class 3 or above)
- •Active infection or malignancy
- •Dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
- •Clinician-reported history of patient non-adherence
研究组 & 干预措施
Time restricted feeding
The study will consist of three phases. In phase I all study subjects will be in the ad libitum feeding phase for one week followed by Phase II. In Phase II the subjects will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for one week. For phase III (final week), patients will be returned to an ad libitum feeding. The first and third phases will serve as control phases, and the second phase will be the experimental phase
干预措施: Time restricted feeding (Behavioral)
结局指标
主要结局
mean glucose
时间窗: in one week of time restricted feeding
change in mean glucose
estimated hemoglobin A1c levels
时间窗: in one week of time restricted feeding
change in estimated hemoglobin A1c levels
次要结局
- body weight(in one week of time restricted feeding)
- serum triglyceride levels(in one week of time restricted feeding)
- Insulin resistance(in one week of time restricted feeding)