Evaluación Del Impacto de la composición Nutricional de la Ingesta y Del Consumo de Alcohol en el Control glucémico Postprandial en Pacientes Con Diabetes Tipo 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Plasma Glucose
研究概览
简要总结
Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of postprandial glucose response is burdensome for patients and healthcare professionals.
To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a certain degree of heterogeneity) that meal composition significantly affects postprandial glucose control, contributing to glycemic variability. Moreover, despite the high prevalence of alcohol consumption among patients with T1DM (about 30%, similar to that of the general population), data regarding its effect on the postprandial period are very limited.
This project will evaluate the effect of meal composition and alcohol consumption on postprandial glucose control in subjects with T1DM under intensive insulin treatment.
详细描述
Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain), single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under intensive insulin treatment.
Aim:
To assess the effect of mixed meal composition on postprandial glycemic control, in subjects with type 1 diabetes:
- Combined effect of proteins and fats
- Effect of alcohol consumption
Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysis will be carried out by a person not involved in the study (she/he will be blind to the study condition)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.
排除标准
- •Pregnancy and lactation
- •Hypoglycemia unawareness
- •Fatal or progressive disease
- •Drugs or alcohol abuse
- •HIV, active hepatitis B, active hepatitis C
- •Hepatic disease (aminotransferases AST or ALT >2 times above normal)
- •Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
- •Pre-planned surgery
- •Blood donation in the previous 3 months for men and 6 months for women
- •Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
- •Non-compliant subjects
- •Use of experimental medications or devices during the previous 30 days
结局指标
主要结局
Plasma Glucose
时间窗: 6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).
Post-prandial plasma glucose time series
次要结局
- AUC-PG(AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.)
研究者
Jorge Bondia
Associate Professor
Universitat Politècnica de València