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NCT04263675 Clinical Trial

Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes

Gestational Diabetes Clinical Trial

— LAIT-M  

Official title:
Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04263675
Other study ID # LAIT-M
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date April 1, 2025

Study information
Verified date April 2022
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Breastfeeding has been associated with decreased obesity. However, this relationship is not as clear in children who have been exposed to GDM and the mechanisms involved are little known. The overall objective of the project is to study the mechanisms of breastfeeding on the growth of children in women who have had a GDM. More specifically, the project want to compare the macronutrient and hormone composition of breast milk of women with and without GDM. Investigators also want to associate the levels of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without DG and the growth of the child. A total of 60 women (30 with GDM and 30 without GDM) will collect breastmilk at 2 months postpartum.

Description:

Other data collected: Waist circumference, DXA, Fasted blood sample, Oral glucose tolerance test, Breastfeeding habits, Food habits, Baby's height et weight.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date April 1, 2025
Est. primary completion date October 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Breastfeeding women Exclusion Criteria: - Type 1 or type 2 diabetes - Preterm birth - History of bariatric surgery - Multiple births

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Institut sur la nutrition et les aliments fonctionnels Quebec City Quebec

Sponsors (1)
Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM. 2 years
Secondary Compare macronutrient and hormone composition of breast milk of women with and without GDM. 6 months
Secondary Associate level of hormones related to satiety and energy metabolism (i.e. endocannabinoids, ghrelin, leptin) in the human milk of women with or without GDM and the growth of the child. 6 months
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