Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

Completed

• Conditions: Gestational Diabetes; Insulin Resistance; Hyperglycemia; Obesity

• Registration Number: NCT01405547
• Lead Sponsor: Anthony Hanley

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-29
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 271

Inclusion Criteria

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

Exclusion Criteria

• pre-existing diabetes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Infant growth	Growth from birth to anthrometry at 12mo

Secondary Outcome Measures

Name	Time	Method
Onset of lactogenesis II	At 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.
Human milk composition	At 3d and at 3mo postpartum
Gestational metabolic abnormalities	An expected average of 30 weeks of gestation
Gestational diabetes	An expected average of 30 weeks of gestation
Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)	An expected average of 30 weeks of gestation

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada