Effects of Meal Timing on Postprandial Glucose, Insulin and GLP-1 Responses After Breakfast Lunch and Dinner in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Postprandial GLP-1 plasma levels, after breakfast,lunch and dinner meal test
研究概览
简要总结
Enhanced insulin and GLP-1 postprandial response after morning meal versus evening meal, might be underlying explanation of the beneficial effect of eating breakfast with reduced dinner vs skipping breakfast on glycemic control and HbA1c in T2D patients.
To test this hypothesis and clarify whether glucose, insulin and GLP-1 postprandial responses are different in the morning vs. in the afternoon, the investigators will compare in T2D subjects in random order and in two separate days: the glucose, insulin and GLP-1 postprandial responses after breakfast, lunch and dinner with 2 isocaloric meal plans or test diets, that differ in meal timing distribution The investigators hypothesize that GLP-1 and insulin response after high calorie breakfast will be higher in comparison to GLP-1 and insulin response after identical meal at evening
详细描述
The endogenous circadian (24-h) timing system, synchronized by light/dark cycle in the master circadian clock in the suprachiasmatic nuclei and by meal timing in the peripheral clock genes; plays a significant role in regulating sleep/wake and feeding behavior, body weight as well as glucose and lipid metabolism.
Circadian misalignment, involving sleep/wake and meal timing schedules 12 h out of phase from their habitual times resulted in elevated blood pressure and increased postprandial glucose and insulin levels. Animal models of circadian misalignment specially breakfast skipping are associated with alteration in the expression pattern of clock genes such as Clock, Bmal1, Cry1, and Per2 in the liver and fat cells. These changes resulted in a predisposition to obesity and type 2 diabetes (T2D). This may also explain why evening or night eating is often associated with weight gain and obesity.
Breakfast skipping has been consistently associated with increased, visceral adiposity, higher BMI and waist circumference, insulin resistance, dyslipidemia and with T2D despite having less total daily caloric intake.
A recent population-based studies have found that participants with an evening preferences (late chronotype) that involves breakfast skipping, have 2.5 times risk of developing T2D, even after adjustment for body mass index (BMI) (12).
Breakfast skipping and greater percentage of their daily caloric intake at dinner was associated with higher fasting plasma glucose levels, and poorer glycemic control compared with earlier chronotypes even after adjusting for BMI (11,20,21). Recently was documented that in T2D patients, breakfast skipping was associated was associated with a 10.8% increase in HbA1C of its original value, even after adjusting for age, sex, race, BMI, number of diabetes complications, insulin use, depressive symptoms, perceived sleep debt, and percentage of daily caloric intake at dinner. This significant difference in HbA1C levels between breakfast skippers and breakfast eaters in patients with T2D, highlights the potential impact of the meal timing on the course of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients
- •HbA1C > 7%
- •Duration of diabetes: 0.5 to 10 years
- •Subjects ≥ 30 and ≤70 years of age
- •BMI: 22 to 35 kg/m2
- •Diet controlled diabetic. Only treatment with metformin will be allowed
- •Normal liver and kidney function
- •Normal thyroid function
- •Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
- •Stable physical activity pattern during the three months immediately preceding study
- •Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:
- •No shift work within 5 years of the study
- •Did not cross time zones within 1 month of the study
- •Read and understood the informed consent form and signed it voluntarily
排除标准
- •Type 1 diabetes
- •Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- •Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
- •Pregnancy or lactation
- •Illicit drug abuse or alcoholism
- •Treatment with antidiabetic drugs, insulin or GLP-1 analogs
- •Subjects taking anoretic drugs during the month immediately prior to study
- •Subjects on steroid treatment
- •Those with eating disorders
- •Subjects after bariatric surgery, will be excluded
结局指标
主要结局
Postprandial GLP-1 plasma levels, after breakfast,lunch and dinner meal test
时间窗: During 3 hours after breakfast, lunch and dinner meal challange
All Type 2 diabetic participants will be randomly assigned to one of 2 isocaloric diet sequences that will differ in the meal timing distribution. The diets will be tested in two separate occasions during a curse of a single day (test day) in which postprandial plasma GLP-1 levels during 3 hours after breakfast, lunch and dinner meal challenge will be measured
次要结局
- Postprandial Plasma Glucose levels after breakfast, lunch and dinner meal challenge(Postprandial Plasma Glucose levels during 3 hours after breakfast, lunch and dinner meal challenge)
研究者
Daniela Jakubowicz
Professor Daniela Jakubowicz MD
Tel Aviv University