Monitoring of Postprandial Glycemic Variability in Healthy Young Infants

NCT03819725 | Completed DMC

• 1 other identifier: CER-VD / 2017-02090
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Conditions; Glucose Intolerance

Keywords

Glucose variation; Infant; Nutrition; interstitial glucose variation

Outcome Measures

Primary Outcomes (1)

• Prandial glucose variations

  Change of preprandial to postprandial glucose measurements, expressed in mmol/l

  up to 5 days

Study Arms (1)

Glucose monitoring

OTHER

FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla® ) and glucose measurements will be monitored during 2-5 days. Oral food intake will be recorded.

Device: Glucose monitoring

Interventions

Glucose monitoring DEVICE

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.

Glucose monitoring

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term infants (boys and girls)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael Hauschild, MF

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Michael Hauschild, MD

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: January 28, 2019
• Study Start: January 14, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

CH (1)