Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

This study has been completed.
Sponsor:
Collaborators:
Canadian Diabetes Association
Canadian Foundation for Dietetic Research (CFDR)
Information provided by (Responsible Party):
Anthony Hanley, University of Toronto
ClinicalTrials.gov Identifier:
NCT01405547
First received: July 12, 2011
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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
Gestational Diabetes
Hyperglycemia
Insulin Resistance
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Infant growth [ Time Frame: Growth from birth to anthrometry at 12mo ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Human milk composition [ Time Frame: At 3d and at 3mo postpartum ] [ Designated as safety issue: No ]
  • Onset of lactogenesis II [ Time Frame: At 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7. ] [ Designated as safety issue: No ]
    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 diabetes [ Time Frame: An expected average of 30 weeks of gestation ] [ Designated as safety issue: No ]
  • Gestational metabolic abnormalities [ Time Frame: An expected average of 30 weeks of gestation ] [ Designated as safety issue: No ]
  • Getational hyperglycemia and insulinemia (insulin resistance/sensitivity) [ Time Frame: An expected average of 30 weeks of gestation ] [ Designated as safety issue: No ]

Enrollment: 271
Study Start Date: March 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pre-existing diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405547

Locations
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T 3L9
Sponsors and Collaborators
Anthony Hanley
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anthony Hanley, Associate Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01405547     History of Changes
Other Study ID Numbers: 488057
Study First Received: July 12, 2011
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Gestational Diabetes
Gestational Hyperglycemia
Gestational Insulinemia
Maternal Obesity
Human Milk
Lactogenesis
Obstetrics
Nutrition
Infant Growth

Additional relevant MeSH terms:
Diabetes, Gestational
Hyperglycemia
Insulin Resistance
Obesity
Body Weight
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Pregnancy Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014