Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
研究概览
简要总结
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character about 10 to 25% of patients develop CF-related diabetes (DRFC). Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis.
详细描述
Cystic fibrosis (CF) is a genetic disease with an autosomal recessive, chronic and progressive character. About 10 to 25% of patients develop CF-related diabetes (DRFC), whose pathogenesis is associated with pancreatic fibrosis and destruction. Until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and CF patients. The objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase. Methods: Randomized clinical trial in patients with CF aged over 10 years without hospitalization in the last 4 weeks. Anthropometric measurements, blood pressure, 24 hour recall and food frequency questionnaire will be evaluated. Oral glucose tolerance and glycated hemoglobin test will be dosed at baseline and during 12 weeks of follow-up. The intervention group will receive a nutritional guidance at the beginning of the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •tolerance glucose test values between 100 and 125mg / dl and or glucose 2h after 75g of glucose between 140 and 199 mg / dl
- •Stable pulmonary disease in the last four weeks
排除标准
- •Without hospitalization in the last 3 months
结局指标
主要结局
glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase
时间窗: 3 months
To evaluate the improvement of glucose levels after the diet intervention. After 12 weeks of intervention will be performed oral glucose tolerance test
次要结局
- To evaluate anthropometric data of the patients before and after the intervention.(3 months)
- Evaluate the response of forced expiratory volume and forced vital capacity before and after the intervention(3 months)
- Evaluate the levels of HbA1c before and after the intervention(3 months)