The Effect of Glycemic Index on Post-prandial Glycemia (Breakfast vs. Lunch) in Patients With Type 1 Diabetes: Quantification With Continuous Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Mean Area Under the Curve for Rise in Breakfast Post-prandial.
研究概览
简要总结
Background: Post-prandial hyperglycemia is common in people with type 1 diabetes.
Objective: The aim was to determine the impact of low vs high glycemic index (GI) on post-prandial glycemia for breakfast vs lunch and to quantify these effects with continuous glucose monitoring.
Design: Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low GI; in the other, high GI. Meals were given 195 minutes apart and were matched for carbohydrate, protein, and fat content. Each subject received his usual pre-prandial insulin dosage, followed by a continuous subcutaneous basal insulin infusion for the remainder of the experiment. Arterialized venous glucose was analyzed every 15 minutes and sensor glucose was recorded every 5 minutes.
详细描述
A total of 14 diet studies (each with two meals) were completed in three men and four women. All subjects completed two diet studies in which two meals were served 195 minutes apart. On one study day, two high GI (> 75) meals were given, and on the other study day, two low GI (< 30) meals were given. The low GI and high GI meals were matched for amount of carbohydrates, protein, and fat based on a weight-maintaining diet for each subject. The order of the study treatment (high or low GI) was randomized. Subjects were not informed as the GI of any meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •clinical diagnosis of type 1 diabetes mellitus
- •patients on insulin pump therapy
排除标准
- •Any patient who was
- •pregnancy
- •cardiovascular, cerebrovascular, kidney, or liver disease
- •uncontrolled chronic medical conditions
- •oral or parenteral corticosteroid use
- •immunosuppressant use
- •visual or physical impairments that impede the use of a continuous glucose monitoring device
- •insulin or glucagon allergy
- •hypoglycemia unawareness
- •requirement of greater than 200 units of insulin per day
- •gastroparesis
- •any prior gastric surgery
- •an allergy to any food items served.
结局指标
主要结局
Mean Area Under the Curve for Rise in Breakfast Post-prandial.
时间窗: Mean area under the curve was calculated at 0, 15min, 30 min, 45 min, 60min, 75 min, 90 min, 105 min, 120min, 135min, 150min, 165min and 180 min after breakfast
Arterialized blood glucose was monitored at 15 minute intervals and sensed glucose was recorded at five minute intervals. Mean area under the curve was calculated over the 3 hour period after breakfast for both the high and low glycemic breakfast meals.
次要结局
未报告次要终点
研究者
W. Kenneth Ward
Senior Scientist
Legacy Health System