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Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01405547
Enrollment
271
Registered
2011-07-29
Start date
2009-03-31
Completion date
2012-08-31
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Hyperglycemia, Insulin Resistance, Obesity

Keywords

Gestational Diabetes, Gestational Hyperglycemia, Gestational Insulinemia, Maternal Obesity, Human Milk, Lactogenesis, Obstetrics, Nutrition, Infant Growth

Brief summary

Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in life. Recent evidence indicates that abnormalities that increase risk for diabetes may be initiated early in infancy. Since the offspring of women with diabetes have an increased long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic abnormalities on early nutrition and infant metabolic trajectories is of considerable interest. The purpose of the study is to investigate the impact of maternal nutrition and metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the first year of life.

Detailed description

The current investigation is a prospective study conducted within ongoing cohort studies of women and their offspring. Pregnant women attending outpatient obstetrics clinics in Toronto, Canada are recruited. The overall study protocol includes four study visits between the second half of pregnancy and the first year of infant's life and interim phone call interviews: * Pregnant women undergo an oral glucose tolerance test at an expected average of 30 weeks of gestation and complete medical and lifestyle questionnaires including food frequency questionnaires. * Infant birth anthropometry measurements and human milk samples are collected at an expected average of 3 days postpartum. The timing of onset of lactogenesis II is asked at 3d, 5d, 7d postpartum or until the event occurrence up to day 7. * At 3 months postpartum, follow-up assessments including infant anthropometry, medical and lifestyle questionnaires and human milk sample collection are completed. * Interim telephone interviews are conducted at 6 weeks and 5, 7, 9 months postpartum to characterize infant feeding and supplementation behaviors. * At 12 months postpartum, infant anthropometric assessments are conducted.

Interventions

None listed

Sponsors

Canadian Diabetes Association
CollaboratorOTHER
Canadian Foundation for Dietetic Research (CFDR)
CollaboratorOTHER
Anthony Hanley
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* singleton or twin pregnancy * aged 20 years or older at the time of recruitment * intention to breastfeed

Exclusion criteria

* pre-existing diabetes

Design outcomes

Primary

MeasureTime frame
Infant growthGrowth from birth to anthrometry at 12mo

Secondary

MeasureTime frameDescription
Human milk compositionAt 3d and at 3mo postpartum
Onset of lactogenesis IIAt 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7.If the participant reports no milk-coming-in at the day 7 postpartum interview, the response is recorded as no milk-coming-in by day 7 postpartum.
Gestational diabetesAn expected average of 30 weeks of gestation
Gestational metabolic abnormalitiesAn expected average of 30 weeks of gestation
Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)An expected average of 30 weeks of gestation

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026