Effectiveness of the Carbohydrate Counting Method on Postprandial Glucose Concentrations After Consumption of Mixed Meals in Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Capillary blood glucose
研究概览
简要总结
In a randomized, cross-over designed study, the investigators examined the effectiveness of the carbohydrate counting method after consumption of mixed meals typical of the Greek cuisine with various protein and fat contents in a sample of people with type 1 diabetes (DM1). The investigators also tried to further explore the effects of additional extra virgin olive oil (11 ml) on the glycemic response.
详细描述
A total of 20 adults with type 1 diabetes on intensive insulin therapy consumed three mixed meals at noon between 1200 and 1300 hours, with and without the addition of 11 ml extra virgin oil, in random order. One week before entering the study, participants kept a detailed 7-day weighed food record with fingerprick blood glucose measurements pre-and-2hour post-meals for calculation of their carbohydrate (g) to insulin (units) ratio. Moreover, the individual correction factor was calculated. Thereafter, insulin requirements for the test meals were calculated based on the carbohydrate content of each dish and according to the personalised carbohydrate to insulin ratio. Postprandial glycemia was measured in capillary blood glucose samples at 30min intervals over 195min. For 24hr before each testing session, participants were asked to refrain from the consumption of alcohol and to maintain their usual physical activity pattern. On the day of testing, subjects were asked to consume their usual breakfast and abstain from food for at least 2 hours before their appointment. If blood glucose was >7.2 mmol/l at 1200, insulin was administered based on the individualised correction factor. If blood glucose was >10 mmol/l at the beginning of the testing session, insulin was administered to correct it and the subject was asked to return on another day. if hypoglycaemia occurred (defined as blood glucose level <3.8 mmol/l), the test session was stopped, the event was recorded and the patient treated appropriately. The on target 2hour postprandial blood glucose level was set between 3.9 and 10 mmol/l. Anthropometric measurements (body weight, waist and hip circumferences) were performed at every visit.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes
- •Intensive insulin therapy
- •HbA1c < 10%
- •>2 years with diabetes
排除标准
- •Food allergies
- •Diabetic neuropathy
- •Kidney disease
- •Hematological disturbances
- •Liver disease
- •Uncontrolled hypo- or hyperthyroidism
- •Arrhythmia
- •Heart disease
- •Serious mental illness
结局指标
主要结局
Capillary blood glucose
时间窗: 195 minutes
Clinically useful change in capillary blood glucose, defined as the restoration of glucose within normal limits during the first two hours and until the end of the trial
次要结局
未报告次要终点
研究者
Aimilia Papakonstantinou
Lecturer in Nutrition and Metabolism Unit of Human Nutrition Dept of Food Science and Human Nutrition Agricultural University Of Athens
Agricultural University of Athens
