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

Active, not recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT04263675
• Lead Sponsor: Laval University

Brief 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.

Detailed Description

Other data collected:

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

Study Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2020-05-01
• Primary Completion: 2020-10-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-14
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Breastfeeding women

Exclusion Criteria

• Type 1 or type 2 diabetes
• Preterm birth
• History of bariatric surgery
• Multiple births

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM.	2 years

Secondary Outcome Measures

Name	Time	Method
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
Compare macronutrient and hormone composition of breast milk of women with and without GDM.	6 months

Trial Locations

Locations (1)

Institut sur la nutrition et les aliments fonctionnels; 🇨🇦 Quebec City, Quebec, Canada