Time Restricted Eating As Treatment (TREAT) for Diabetes Mellitus: A Pre-Post 12 Week Study on the Effectiveness of Intermittent Fasting in Asians With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in glycaemic control of patients as measured by >= 5% reduction in glycosylated haemoglobin (HbA1C) over a 12 week period.
研究概览
简要总结
Type 2 Diabetes Mellitus (DM) is a silent epidemic that affects 11.3% of Singaporeans. It has numerous clinical sequelae including macrovascular and microvascular disease. Nutritional therapy has been widely accepted as being safe and affordable as compared to pharmacotherapy. It is estimated that current nutritional therapy is able to reduce HbA1c levels by 1 to 2 percent under ideal circumstances. A weight loss of >5% is needed to have any significant beneficial effects on the levels of HbA1c, lipids, and blood pressure. This requires extensive modification of lifestyle, calorie restriction, regular exercise, and close supervision by health care professionals; impracticable for most patients. Intermittent Fasting that has been shown to be effective in improving the metabolic state of human subjects. The investigators ask if a simpler dietary regime based on time restricted eating would produce the necessary weight loss and good metabolic outcome.
In this pilot single arm pre-post study, 50 adult diabetic patients will be educated on Time Restricted Eating As Treatment (TREAT). Under this intervention, subjects will skip one meal a day and aim for a fasting period 16 hours a day. In the 8 hours where eating is permitted, subjects are encouraged to eat normally based on what is recommended for diabetic patients in usual care. Relevant clinical parameters, such as blood glucose control, lipid and triglyceride levels and anthropometry will be monitored over a 12-week period.
This study would have major clinical impact if it is found that TREAT can result in the improvement of cardiometabolic parameters and is practicable and sustainable in a real world setting.
详细描述
Nutritional therapy for diabetes mellitus is widely accepted as safe and affordable when compared to pharmacotherapy. However, the efficacy of the present state of nutritional therapy based on current recommendations is poor. It is estimated that nutritional therapy is able to reduce HbA1c levels by 1 to 2 percent under ideal circumstances. A weight loss of >5% is needed to have any significant beneficial effects on the levels of HbA1c, lipids, and blood pressure. This would require extensive modification of lifestyle, including calorie restriction, regular exercise, and close supervision by health care professionals. For the majority of patients, adherence to such a regime on a long-term basis is not achievable or practical.Considerable effort is required to educate and reinforce the complex behavioural changes needed. A simpler dietary regime that would produce the necessary weight loss and good metabolic outcome is needed.
Rationale for use of Intermittent Fasting as Nutritional Therapy: Practicability, Efficacy and Safety.
Intermittent fasting (IF) has been practiced by humans since ancient times, out of necessity and for religious purposes. Numerous regimens of intermittent fasting exist:
- Alternate-day fasting, with either a total fast or restriction of energy 60-70% below estimated requirements on alternate days.
- Modified Fasting Regimens (such as the 5:2 diet which involves severe energy restriction for 2 non-consecutive days in a week and ad libitum eating for the other 5 days), a variant of alternate-day fasting.
- Time-restricted Feeding where intake is restricted to a pre-defined time window daily, and fasting occurs for 12-21 hours of the day.
There is experimental and evolutionary evidence across microbes and animals that such fasting improves cardiometabolic health and survival. In mice, the preservation of beta cell function occurs through the mechanism of autophagy during fasting, and survival is prolonged in bacteria, yeasts, worms and mice when fasting that has been attributed to an alternative ketone-body like energy source during periods of caloric deprivation. The mechanisms of action proposed are that fasting triggers adaptive cellular stress responses, resulting in an enhanced ability to cope with more severe stress and counteract disease processes. In addition, by protecting cells from DNA damage, suppressing cell growth and enhancing apoptosis of damaged cells, fasting could retard and/or prevent the formation and growth of cancers.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects (male or female) ≥ 21 to 80 years of age at Visit
- •Subjects newly diagnosed with Type II diabetes mellitus (DM) who are solely on dietary control.
- •Ability to sign written informed consent before any study-specific procedure.
- •Subject is considered reliable and capable of adhering to protocol.
- •Subjects with Body Mass Index (BMI)≥ 23.5kg/m2.
排除标准
- •Subjects on Type II diabetes medication.
- •Subjects with any of the following medical conditions:
- •Congestive cardiac failure.
- •Stage 4 or worse chronic kidney disease (i.e. eGFR < 30 ml/min/1.73 m2)
- •Child's B or worse liver cirrhosis.
- •Any medical condition that in the opinion of the investigator could jeopardize or compromise the subject's ability to participate in the study.
- •Subject with previous or present history of eating disorder.
- •Subject not able to understand the informed consent form or fasting diary instructions.
- •Subject has participated in another study of an investigational medication or an investigational medical device within the last 30 days or is currently participating in these studies.
- •Subject is pregnant or lactating.
结局指标
主要结局
Change in glycaemic control of patients as measured by >= 5% reduction in glycosylated haemoglobin (HbA1C) over a 12 week period.
时间窗: 12 weeks
次要结局
- Change in a levels of ketonemia (Serum Beta-Hydroxybutyrate 0.5-3.0 mmol/L) over a 12 week period.(12 weeks)
- Change in glycaemic control of patients as measured by fasting glucose and 2 hour post prandial glucose over a 12 week period.(12 weeks)
- Change in the lipid profiles of patients, namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides (TG), over a 12 week period.(12 weeks)
- Change in Blood Pressure (BP) over a 12 week period.(12 weeks)
- Change in Weight over a 12 week period.(12 weeks)
- Change in Body Mass Index (BMI) over a 12 week period.(12 weeks)
- Change in Waist Circumference (WC) over a 12 week period.(12 weeks)