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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

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