Effect of Breakfast Omission on Postprandial Glycemia After Lunch and Dinner in T2D
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Postprandial Glucose Response
研究概览
简要总结
The investigators will explore the effect of omission of breakfast on postprandial hyperglycemia and insulin and intact GLP-1 response after subsequent meals in type 2 diabetic patients
详细描述
In obesity and in type 2 diabetes eating behavior especially the lack of breakfast promote weight gain, increase hunger and carbohydrate craving.
The present study is designed to address whether in T2D, a change in meal timing; specifically, by adding calories, protein and carbohydrates to the breakfast vs.the omission of breakfast will influence the postprandial elevation of glucose, insulin, intact GLP-1, glucagon and free fatty acids (FFA) after subsequent meals at lunch and dinner.
The investigators expect that compared to the day with breakfast condition the day when the breakfast will be omitted the postprandial glucose , free fattly acids, and glucagon response after lunch and dinner will be significative higher while insulin and intact GLP-1 response after lunch and dinner will be reduced
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetics for < 10yr
- •HbA1C: 7-9 %
- •BMI: 22 to 35 kg/m2)
- •Age: ≥30 and ≤70 years of age
- •Habitually eat breakfast
- •Naïve or treated with oral antidiabetic drugs and those with anti-hypertensive and lipid-lowering medication
- •Those treated with insulin or GLP-1 analogs or having major liver, heart or kidney illnesses will be excluded.
- •Usually wake up between 06:00 and 07:00 and go to sleep between 22:00 and 24:
- •Not dieting and no change in body weight >10 lb = 4.5 kg within the last 6 months
- •Stable physical activity pattern during the three months immediately preceding study initiation
- •Normal liver and kidney function 12 No metabolic disease other then diabetes
- •Usually wakes up between 05:00 and 07:00 and goes to sleep between 22:00 and 24:
- •Normal TSH and FT4 levels
- •Acceptable health based on interview, medical history, physical examination, and laboratory tests
- •Those who provide signed informed consent
排除标准
- •Type 1 diabetes
- •Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
- •Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
- •Anemia (Hg > 10g/dL)
- •Serum creatinine level > 1.5 mg/dl
- •Pregnant or lactating
- •Participating in another dietary program or use of weight-loss medications
- •Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
- •Use of psychotropic or anoretic medication during the month immediately prior to study onset
- •13.Work shifts within the last 5 years and did not cross time zones within the last month of the study.
研究组 & 干预措施
Omitted Breakfast
Experimental: The patients in Omitted Breakfast day will omit the breakfast and will continue the fast until noon. Thereafter will eat Lunch at 13;30 and Dinner at 19:00
干预措施: Omitted Breakfast (Other)
Omitted Breakfast
Experimental: The patients in Omitted Breakfast day will omit the breakfast and will continue the fast until noon. Thereafter will eat Lunch at 13;30 and Dinner at 19:00
干预措施: Breakfast (Other)
Breakfast
The patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00
干预措施: Omitted Breakfast (Other)
Breakfast
The patients in Breakfast day will consume breakfast at 8:00 and then lunch at 13;30 and dinner at 19:00
干预措施: Breakfast (Other)
结局指标
主要结局
Postprandial Glucose Response
时间窗: 12 weeks
Postprandial Glucose response will be measure after lunch and dinner
次要结局
- Postprandial Insulin Response(12 weeks)
- Postprandial intact-GLP-1 Response(12 weeks)
- Postprandial Glucagon Response(12 weeks)
- Postprandial Free Fatty Acids Response(12 weeks)
研究者
Daniela Jakubowicz
Prof. Daniela Jakubowicz MD
Tel Aviv University