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Monitoring of Postprandial Glycemic Variability in Healthy Young Infants (IGVM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819725
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : June 22, 2021
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
Michael Hauschild, University of Lausanne Hospitals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infant Conditions Glucose Intolerance Device: Glucose monitoring Not Applicable

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 .

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring of Postprandial Glycemic Variability in Healthy Young Infants
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : April 30, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Glucose monitoring
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Prandial glucose variations [ Time Frame: up to 5 days ]
    Change of preprandial to postprandial glucose measurements, expressed in mmol/l


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819725


Locations
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Switzerland
Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Nestlé
Investigators
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Principal Investigator: Michael Hauschild, MF CHUV
More Information
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Responsible Party: Michael Hauschild, Dr. Michael Hauschild, MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT03819725    
Other Study ID Numbers: CER-VD / 2017-02090
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Hauschild, University of Lausanne Hospitals:
Glucose variation
Infant
Nutrition
interstitial glucose variation
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases