Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

November 27, 2023 updated by: Anthony Hanley

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

271

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 3L9
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women are recruited in outpatient clinic waiting areas at Mount Sinai Hospital in Toronto, Canada, a large tertiary care centre.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Infant growth
Time Frame: Growth from birth to anthrometry at 12mo
Growth from birth to anthrometry at 12mo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Human milk composition
Time Frame: At 3d and at 3mo postpartum
At 3d and at 3mo postpartum
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.
At 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7.
Gestational diabetes
Time Frame: An expected average of 30 weeks of gestation
An expected average of 30 weeks of gestation
Gestational metabolic abnormalities
Time Frame: An expected average of 30 weeks of gestation
An expected average of 30 weeks of gestation
Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)
Time Frame: An expected average of 30 weeks of gestation
An expected average of 30 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthony Hanley

Collaborators

Canadian Diabetes Association
Canadian Foundation for Dietetic Research (CFDR)

Investigators

  • Study Chair: Anthony Hanley, PhD, University of Toronto
  • Study Director: Sylvia Ley, PhD, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimated)

July 29, 2011

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 488057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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