Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

Glucose Intolerance Clinical Trial

— IGVM  

Official title:

Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819725
• Other study ID #: CER-VD / 2017-02090
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Infant Conditions

Intervention

Device:
• Glucose monitoring
FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla®) . Interstitial glucose measurements will be recorded during 2-5 days and during meals.

Locations

Country	Name	City	State
Switzerland	Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prandial glucose variations	Change of preprandial to postprandial glucose measurements, expressed in mmol/l	up to 5 days