Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405547
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : December 20, 2012
Canadian Diabetes Association
Canadian Foundation for Dietetic Research (CFDR)
Information provided by (Responsible Party):
Anthony Hanley, University of Toronto

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.

Condition or disease
Gestational Diabetes Hyperglycemia Insulin Resistance Obesity

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
Actual Enrollment : 271 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development
Study Start Date : March 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Infant growth [ Time Frame: Growth from birth to anthrometry at 12mo ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
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.

Inclusion Criteria:

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

Exclusion Criteria:

  • pre-existing diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405547

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T 3L9
Sponsors and Collaborators
Anthony Hanley
Canadian Diabetes Association
Canadian Foundation for Dietetic Research (CFDR)
Study Chair: Anthony Hanley, PhD University of Toronto
Study Director: Sylvia Ley, PhD University of Toronto

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anthony Hanley, Associate Professor, University of Toronto Identifier: NCT01405547     History of Changes
Other Study ID Numbers: 488057
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Anthony Hanley, University of Toronto:
Gestational Diabetes
Gestational Hyperglycemia
Gestational Insulinemia
Maternal Obesity
Human Milk
Infant Growth

Additional relevant MeSH terms:
Insulin Resistance
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus
Endocrine System Diseases