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Completed

NCT Number: NCT01405547

Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pre-existing diabetes

Treatment and study plan

Primary outcomes

  1. Infant growth

    Time frame: Growth from birth to anthrometry at 12mo

Secondary outcomes

  1. Human milk composition

    Time frame: At 3d and at 3mo postpartum

  2. Onset of lactogenesis II

    Time frame: 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.

  3. Gestational diabetes

    Time frame: An expected average of 30 weeks of gestation

  4. Gestational metabolic abnormalities

    Time frame: An expected average of 30 weeks of gestation

  5. Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)

    Time frame: An expected average of 30 weeks of gestation

Sponsors and collaborators

Lead sponsor

Anthony Hanley

Other

Collaborators

  • Canadian Diabetes Association
  • Canadian Foundation for Dietetic Research (CFDR)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 29, 2011
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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