Monitoring of Postprandial Glycemic Variability in Healthy Young Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Prandial glucose variations
研究概览
简要总结
To measure and quantify the postprandial glucose variations in response to a meal in the healthy 6-12 months old child and correlate this response with the composition of this meal.
详细描述
14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations will be recruited. Children will be recruited in the Lausanne Childrens hospital and only be included in the study whenin good general health.
FreeStyle® Libre Pro Interstitial Glucose Meter will be applied on the last day before discharge from the hospital after skin preparation with anesthetic cream (Emla®) during hospitalization and measurements will be recorded during 2-5 days.
It is not intended to measure capillary or venous blood glucose levels during this study. However, if blood is collected during hospitalization, blood glucose will be measured in parallel with the interstitial glucose measured with the device.
The child will follow his usual diet without modifications. The amount of food consumed by the child as well as the length of the meals will be recorded by the parents. For meals made by the parents they will be asked to keep a sample not seen to analyze their carbohydrate content. The total carbohydrate content will be measured .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Term infants (boys and girls)
- •6 to 12 months old
- •In good general health
- •Nourished with diverse nutrition including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations
- •Infant child: if the child is breastfed partially, it can be included in the study. In this case, only samples of a food supplement will be collected for evaluation of the composition.
- •Hospitalized at the Lausanne Children's Hospital for non-severe reasons that do not affect or suspect to affect glucose metabolism
- •Measures of feeding (time and compositions with samples) feasible for 3 consecutive days by the parents at home
排除标准
- •Child born premature
- •One or both parents with type 2 diabetes or gestational diabetes
- •Child totally breastfed
- •Chronic skin condition such as eczema, excessive dryness.
- •Allergy known to adhesive plaster
- •Infectious diseases affecting the skin (eg chickenpox, scarlet fever,)
- •disorders of cutaneous microcirculation
- •Infants suffering from diseases affecting nutrition or digestion (diarrheal gastroenteritis) and children undergoing antibiotic treatment that may affect gastrointestinal absorption
- •Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or Diathermy Therapy
结局指标
主要结局
Prandial glucose variations
时间窗: up to 5 days
Change of preprandial to postprandial glucose measurements, expressed in mmol/l
次要结局
未报告次要终点
研究者
Michael Hauschild
Dr. Michael Hauschild, MD
University of Lausanne Hospitals