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CompletedNCT01405547Updated Nov 28, 2023

Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

An observational study in Gestational Diabetes, Hyperglycemia and Insulin Resistance, sponsored by Anthony Hanley. Completed at 1 site in Canada. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.

Sponsored by Anthony Hanley · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
271
Ages
20 Years to 45 Years
Sex
Female
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Study 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.

Read the 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.
02

Conditions studied

  • Gestational Diabetes
  • Hyperglycemia
  • Insulin Resistance
  • Obesity

Keywords

  • Gestational Diabetes
  • Gestational Hyperglycemia
  • Gestational Insulinemia
  • Maternal Obesity
  • Human Milk
  • Lactogenesis
  • Obstetrics
  • Nutrition
  • Infant Growth
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.

This study's enrollment of 271 is above the median of 198 across 270 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

This is the only study on the registry with Anthony Hanley as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

Exclusion Criteria:

  • pre-existing diabetes
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
271 participants (actual)
06

What researchers measure

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

    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.

    Time frame: At 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7.

  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

07

Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5T 3L9, Canada
08

References and documents

Publications

  • Ley SH, O'Connor DL, Retnakaran R, Hamilton JK, Sermer M, Zinman B, Hanley AJ. Impact of maternal metabolic abnormalities in pregnancy on human milk and subsequent infant metabolic development: methodology and design. BMC Public Health. 2010 Oct 6;10:590. doi: 10.1186/1471-2458-10-590. PubMed 20925937 ↗
  • Ley SH, Hanley AJ, Sermer M, Zinman B, O'Connor DL. Associations of prenatal metabolic abnormalities with insulin and adiponectin concentrations in human milk. Am J Clin Nutr. 2012 Apr;95(4):867-74. doi: 10.3945/ajcn.111.028431. Epub 2012 Feb 29. PubMed 22378730 ↗
  • Ley SH, Hanley AJ, Retnakaran R, Sermer M, Zinman B, O'Connor DL. Effect of macronutrient intake during the second trimester on glucose metabolism later in pregnancy. Am J Clin Nutr. 2011 Nov;94(5):1232-40. doi: 10.3945/ajcn.111.018861. Epub 2011 Sep 28. PubMed 21955650 ↗
  • LeMay-Nedjelski L, Butcher J, Ley SH, Asbury MR, Hanley AJ, Kiss A, Unger S, Copeland JK, Wang PW, Zinman B, Stintzi A, O'Connor DL. Examining the relationship between maternal body size, gestational glucose tolerance status, mode of delivery and ethnicity on human milk microbiota at three months post-partum. BMC Microbiol. 2020 Jul 20;20(1):219. doi: 10.1186/s12866-020-01901-9. PubMed 32689933 ↗
  • Ley SH, Hanley AJ, Sermer M, Zinman B, O'Connor DL. Lower dietary vitamin E intake during the second trimester is associated with insulin resistance and hyperglycemia later in pregnancy. Eur J Clin Nutr. 2013 Nov;67(11):1154-6. doi: 10.1038/ejcn.2013.185. Epub 2013 Sep 25. PubMed 24065066 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01405547
Lead sponsor
Anthony Hanley
Collaborators
Canadian Diabetes Association, Canadian Foundation for Dietetic Research (CFDR)
Responsible party
Anthony Hanley (Associate Professor, University of Toronto) — Sponsor-investigator
First posted
Jul 29, 2011
Start date
Mar 2009
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Nov 28, 2023

Study contacts

Anthony Hanley, PhD
study chair · University of Toronto
Sylvia Ley, PhD
study director · University of Toronto
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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