Clinical trial NCT03819725: Monitoring of Postprandial Glycemic Variability in Healthy Young Infants
Official title: Monitoring of Postprandial Glycemic Variability in Healthy Young Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Conditions
Glucose Intolerance
Keywords: Glucose variation
Infant
Nutrition
interstitial glucose variation
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2019-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prandial glucose variations
timeFrame: up to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital
state: Vaud
Study officials:
affiliation: CHUV
name: Michael Hauschild, MF
role: PRINCIPAL_INVESTIGATOR
References: