Gestational DiabetesLAIT-MNCT04263675
Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes
An observational study of Gestational Diabetes, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2020to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with or without GDM
Who may be able to join
- Breastfeeding women
Who cannot join
- Type 1 or type 2 diabetes
- Preterm birth
- History of bariatric surgery
- Multiple births
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut sur la nutrition et les aliments fonctionnels
Québec, Quebec, G1V0A6
About this study
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.
Read the detailed description
Other data collected:
Waist circumference, DXA, Fasted blood sample, Oral glucose tolerance test, Breastfeeding habits, Food habits, Baby's height et weight.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GDM+ | Women with history of gestational diabetes | |
| GDM- | Women without history of gestational diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM.
Measured: 2 years
Secondary outcomes (2)
Compare macronutrient and hormone composition of breast milk of women with and without GDM.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 May 2020
- Primary completion20 Oct 2020
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Robitaille, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263675
- Sponsor's protocol ID
- LAIT-M
- Acronym
- LAIT-M
- Status last verified
- Apr 2022
- First submitted
- 7 Feb 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40275186Fradet 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.
PubMed 38938519
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk: Understanding the Mechanisms Linked to the Prevention of Obesity and Diabetes in Children Exposed in Utero to Gestational Diabetes
- ClinicalTrials.gov ID
- NCT04263675
- Acronym / sponsor ID
- LAIT-M / LAIT-M
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 20 Oct 2020 (actual)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM+ | – | –Women with history of gestational diabetes |
| GDM- | – | –Women without history of gestational diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with or without GDM
Key inclusion criteria (1 listed)
- Breastfeeding women
Key exclusion criteria (4 listed)
- Type 1 or type 2 diabetes
- Preterm birth
- History of bariatric surgery
- Multiple births
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM.
Time frame: 2 years
2 secondary outcomes
Compare macronutrient and hormone composition of breast milk of women with and without GDM.
Time frame: 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.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 40275186Petitclerc 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.
- Derived from this study: PubMed 38938519Fradet 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.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the mechanisms linked to the effect of breastfeeding on the growth of children in women who have had GDM. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263675, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.