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

NCT04263675 | Unknown

• 1 other identifier: LAIT-M
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM.

  2 years

Secondary Outcomes (2)

• Compare macronutrient and hormone composition of breast milk of women with and without GDM.

  6 months

• 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

Study Arms (2)

GDM+

Women with history of gestational diabetes

GDM-

Women without history of gestational diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with or without GDM

You may qualify if:

• Breastfeeding women

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Institut sur la nutrition et les aliments fonctionnels

Québec, Quebec, G1V0A6, Canada

Location

Related Publications (2)

• Petitclerc I, Perron J, Dugas C, Mayer T, Raymond F, Di Marzo V, Veilleux A, Robitaille J. Association between gestational diabetes mellitus, maternal health and diet, and gut microbiota in mother-infant dyads. BMC Pregnancy Childbirth. 2025 Apr 24;25(1):486. doi: 10.1186/s12884-025-07584-2.

  PMID: 40275186 DERIVED

• Fradet A, Castonguay-Paradis S, Dugas C, Perron J, St-Arnaud G, Marc I, Doyen A, Flamand N, Dahhani F, Di Marzo V, Veilleux A, Robitaille J. The human milk endocannabinoidome and neonatal growth in gestational diabetes. Front Endocrinol (Lausanne). 2024 Jun 13;15:1415630. doi: 10.3389/fendo.2024.1415630. eCollection 2024.

  PMID: 38938519 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: May 1, 2020
• Primary Completion: October 20, 2020
• Study Completion: April 1, 2025
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)