NCT03802253进行中（未招募）不适用
Study to Evaluate the Effects of Time-Restricted Eating Regimen in Overweight/Obese Subjects With Impaired Glucose Regulation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Incidence of regression to normoglycaemia among the studied population
研究概览
简要总结
We evaluated the effects of Time-Restricted Eating (TRE) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Aged ≥ 18 year
- •Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment
- •Body mass index (BMI)of 23.0 to 45.0 kg/m2;
排除标准
- •Confirmed diagnosis of DM or on hypoglycaemic treatment
- •Women who are pregnant or breast-feeding at recruitment
- •Patients taking glucocorticoid at recruitment
- •Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
- •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;
- •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 or weight change in the past 3 months (> 5% current body weight) ;
- •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.
研究组 & 干预措施
TRE
Experimental
Participants in this group will focus on time restricted eating (TRE) in addition to daily calorie restriction.
干预措施: Time Restricted eating(TRE) (Behavioral)
RCD
Active Comparator
Participants in this group will focus on standard care with daily reduced calorie diet (RCD)
干预措施: Reduced Calorie Diet (RCD) (Behavioral)
结局指标
主要结局
Incidence of regression to normoglycaemia among the studied population
时间窗: 12 months
次要结局
- Changes in waist circumference (cm)(3 months, 6 months and 12 months)
- Change in body mass index (kg/m2)(3 months, 6 months and 12 months)
- Changes in systolic pressure (mmHg)(3 months, 6 months and 12 months)
- Changes in diastolic pressure (mmHg）(3 months, 6 months and 12 months)
- Changes in serum triglyceride levels (mmol/L)(3 months, 6 months and 12 months)
- Changes in serum high density lipoprotein cholesterol levels (mmol/L)(3 months, 6 months and 12 months)
- Changes in serum aspartate aminotransferase levels (mmol/L)(3 months, 6 months and 12 months)
- Changes in serum gamma glutamyltranspeptidase levels (mmol/L)(3 months, 6 months and 12 months)
- Changes in body weight (Kilograms)(3 months, 6 months and 12 months)
- Change in β cell function(3 months, 6 months and 12 months)
- Changes in serum alanine aminotransferase levels levels (mmol/L)(3 months, 6 months and 12 months)
- Changes in Epworth sleepiness scores（ESS)(3 months, 6 months and 12 months)
- Changes in fasting blood glucose (mmol/L)(3 months, 6 months and 12 months)
- Change in insulin sensitivity(3 months, 6 months and 12 months)
- Changes in serum total cholesterol levels (mmol/L)(3 months, 6 months and 12 months)
- Changes in serum low density lipoprotein cholesterol levels (mmol/L)(3 months, 6 months and 12 months)
- Changes in controlled attenuation parameter(dB/m)(3 months, 6 months and 12 months)
- Changes in Changes in liver fibrosis(3 months, 6 months and 12 months)
- Changes in depressive symptoms(3 months, 6 months and 12 months)
- Incidence of impaired glucose regulation progressing to diabetes(12 months)
- Changes in HbA1c level (%)(Time Frame: 3 months, 6 months and 12 months)
- Change in serum fasting insulin levels (pmol/L)(3 months, 6 months and 12 months)
研究者
研究点 (1)
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