NCT02854202Unknown不适用
Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes
Hospital de Clinicas Caracas0 个研究点目标入组 60 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Plasma glucose
研究概览
简要总结
The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).
详细描述
It was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals This study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (PPHG) in T2D individuals.
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
- 30 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants: from 30 to 72 years of age
- •BMI: 26 to 34 kg/m2)
- •Diabetes criteria
- •HbA1C: 7-9 % or
- •Habitually eat breakfast
- •Only naïve or treated with metformin.
- •Not dieting and no change in body weight >10 lb = 4.5 kg within the last 3 months
- •Normal liver, kidney and thyroid function.
排除标准
- •Type 1 Diabetes
- •Anemia (Hg > 10 g/dL)
- •Serum creatinine level < 1.5 mg/dl
- •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
- •Infectious disease
- •Pregnant women or lactating
- •Known hypersensitivity to milk components
- •Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
结局指标
主要结局
Plasma glucose
时间窗: 3 month
Overall postprandial glycemia after breakfast, lunch and dinner
次要结局
- Satiety(3 month)
- Change in body weight(3 month)
研究者
Daniela Jakubowicz, MD
Professor
Hospital de Clinicas Caracas
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