Diet, Physical Activity and Glucose Tolerance in Cystic Fibrosis. Exploratory Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Measurement of glycemia and insulinemia at T0, T60 and T120 min
研究概览
简要总结
Background :
Diabetes is correlated to an increase in patient morbidity and mortality. The pathophysiology of diabetes is still poorly understood. Significant variations in blood sugar have been shown over time in patients with cystic fibrosis with or without diabetes. No study has evaluated the association between the nutritional profile and the glucose tolerance in adult with cystic fibrosis, by integrating data on energy consumption (detailed nutritional profile) and energy expenditure (rest energy expenditure, body composition, and physical activity).
Given the epidemiological changes in cystic fibrosis correlated to the increased prevalence of diabetes and the clinical impact of nutritional status, the association between these factors remains to be studied.
Objectives of the study :
- Main objective :
To describe adult patients with cystic fibrosis in terms of :
- Nutritional profile
- Food behaviour
- Physical activity
- Rest energy expenditure
- Body composition - Secondary objectives : To research the association between the nutritional profile and the glucose tolerance.
详细描述
Study design :
The study will last 12 months. It's an observational cross-sectional study; patients are include during a scheduled review at the Cystic Fibrosis Resource and Competence Centre (CRCM de Lyon) and their participation lasts only one day. The inclusion period will last 12 months.
Expected results
The expected results are:
- Identify the inter-relationships between nutritional profile and glucose tolerance in adult patients with cystic fibrosis
- Describe the body composition and consumption on resting energy of adults with cystic fibrosis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient (male or female) with cystic fibrosis aged 18 years and over
- •pancreatic insufficiency
- •followed at the CRCM adult in Lyon
- •patient able to understand the information given to him
- •patient having previously had a medical examination during the selection visit
排除标准
- •FEV < 30%
- •lung transplant
- •patient treated with insulin
- •parenteral feeding on nasogastric tube or gastrostomy
- •patient under guardianship or protected by law
- •patient deprived of his liberty by judicial or administrative decision
- •patient currently in an another clinical study
结局指标
主要结局
Measurement of glycemia and insulinemia at T0, T60 and T120 min
时间窗: At baseline
Glucose tolerance is the factor studied. It's established on the basis of Oral Glucose Tolerance Test (OGTT) data, with measurement of glycemia and insulinemia at T0, T60 and T120 min. Carbohydrate status will be determined using the international classification: * Normal Glucose Tolerance (NGT) (G0 ≤ 7.0 mmol / L and G2 ≤ 7.7 mmol / L), * Abnormal glucose tolerance (AGT) defined by indeterminate status (INDET) (G0 ≤ 7.0 mmol / L and G2 ≤ 7.7 mmol / L, but G1 ≥ 11.1 mmol / L) or Impaired Glucose Tolerance (IGT) (G0 ≤ 7.0 mmol / L and G2\> 7.7 mmol / L but \<11.1 mmol / L) * Diabetic status (CFRD) (G0\> 7.0 mmol / L or G2 ≥ 11.1 mmol / L).
次要结局
未报告次要终点