Effects of Intermittent Eating on Glucose Homeostasis in Prediabetes: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring.
研究概览
简要总结
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care.
详细描述
Prediabetes is a high-risk state for diabetes development, lifestyle modification is the cornerstone of diabetes prevention. Two novel types of intermittent fasting recently have received more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on glucose control in type 2 diabetes. No much is known about the effects and molecular mechanisms by TRE or the 5:2 diet improves glucose homeostasis in prediabetes. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on glucose homeostasis and cardiometabolic risk factors in prediabetes over 6 months compared to usual health care. All eligible participants will participate in an 8-week run-in phase in which they are fed the low-calorie-diet. Participants who pass the run-in phase will be randomly assigned 1:1:1 to one of the three study groups (TRE, the 5:2 diet and control groups). Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18-75 years;
- •Prediabetes;
- •Body mass index (BMI)of 28.0 to 45.0 kg/m2;
排除标准
- •History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- •Diagnosis of type 1 and type 2 diabetes;
- •History of malignant tumors;
- •Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- •History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- •History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
- •History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
- •Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- •Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- •Currently participating in weight loss programs;
- •Women who are pregnant or plan to become pregnant;
- •Patients who cannot be followed for 24 months (due to a health situation or migration);
- •Patients who are unwilling or unable to give informed consent.
结局指标
主要结局
Change in percent of time in range (glucose between 3.9-7.8mmol/L) over 6 months measured with continuous glucose monitoring.
时间窗: Baseline to months 6
次要结局
- Change in blood lipids(Baseline and months 6)
- Change in mean glucose levels(Baseline and months 6)
- Change in percent of time above range(Baseline and months 6)
- Change in bile acid level(Baseline and months 6)
- Change in glycemic variability(Baseline and months 6)
- Change in percent of time below range(Baseline and months 6)
- Change in resting metabolic rate(Baseline and months 6)
- Change in gut microbiome composition(Baseline and months 6)
- Change in body weight(Baseline and months 6)
- Change in β cell function(Baseline and months 6)
- Change in body composition(Baseline and months 6)
- Change in waist circumference(Baseline and months 6)
- Change in body mass index(Baseline and months 6)
- Change in liver fat(Baseline and months 6)
- Change in Systolic Blood pressure(Baseline and months 6)
- Change in quality of life(Baseline and months 6)
- Change in HbA1c(Baseline and months 6)
- Change in visceral fat(Baseline and months 6)
- Change in Diastolic Blood pressure(Baseline and months 6)
- Change in pulse wave velocity (PWV)(Baseline and months 6)
- Change in insulin sensitivity(Baseline and months 6)
研究者
Huijie Zhang
Professor
Nanfang Hospital, Southern Medical University