Effect of Food Order on Postprandial Glucose Excursions in Pre-Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effect of food order on postprandial glucose excursions as measured by incremental glucose peaks (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
研究概览
简要总结
The natural history of type 2 diabetes commonly follows a pattern of postprandial dysregulation followed by fasting hyperglycemia leading to overt type 2 diabetes. Approximately 38% of the US adult population is estimated to have pre-diabetes. In a previous study of 16 overweight/obese patients with metformin treated type 2 diabetes, using a typical Western meal, investigators demonstrated that a food order in which protein and vegetables are consumed first, before carbohydrate, results in significant lowering of incremental glucose peaks compared to the reverse order. In the present study, investigators seek to expand on the previous findings to gain further insight into the impact of food order in individuals with pre-diabetes, using a meal with different macronutrient composition, in the setting of three meal patterns. The study is designed to be a simple, practical intervention that may have very significant clinical implications for prevention of diabetes in a large population at increased metabolic risk.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between 30-65 years of age
- •BMI 25-40kg/m2
- •HbA1c 5.7%-6.4%
- •Willing to comply with study requirements
- •Provide written informed consent
排除标准
- •Known diagnosis of diabetes / taking any medication for treatment of diabetes
- •History of previous bariatric surgery
- •History of chronic liver or renal disease
- •Current treatment with systemic corticosteroids
- •Pregnant women
- •History of allergy to any component of the test meal
结局指标
主要结局
Effect of food order on postprandial glucose excursions as measured by incremental glucose peaks (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
时间窗: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial glucose excursions as measured by post prandial glucose levels (mg/dl) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
时间窗: 30, 60, 90, 120, 150 and 180 mins
Effect of food order on postprandial glucose excursions as measured by incremental area under the curve (iAUC) for glucose ((mg/dl)*180) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes
时间窗: 0-180 min
次要结局
- Effect of food order on satiety as measured by a visual analog scale (cm) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes(0,60,120, and 180 mins)
- Effect of food order on postprandial insulin levels (microIU/ml) in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes(30, 60, 90, 120, 150 and 180 mins)
- Effect of food order on postprandial insulin incremental area ((microIU/ml)*180min) under the curve in the setting of 3 commonly followed meal patterns in overweight/obese patients with pre-diabetes(0-180 mins)