NCT01405547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

3.4 years

First QC Date

July 12, 2011

Last Update Submit

November 27, 2023

Conditions

Gestational DiabetesHyperglycemiaInsulin ResistanceObesity

Keywords

Gestational DiabetesGestational HyperglycemiaGestational InsulinemiaMaternal ObesityHuman MilkLactogenesisObstetricsNutritionInfant Growth

Outcome Measures

Primary Outcomes (1)

  • Infant growth

    Growth from birth to anthrometry at 12mo

Secondary Outcomes (5)

  • Human milk composition

    At 3d and at 3mo postpartum

  • Onset of lactogenesis II

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

  • Gestational diabetes

    An expected average of 30 weeks of gestation

  • Gestational metabolic abnormalities

    An expected average of 30 weeks of gestation

  • Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)

    An expected average of 30 weeks of gestation

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • pre-existing diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5T 3L9, Canada

Location

Related Publications (5)

  • 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.

    PMID: 20925937BACKGROUND

  • 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.

    PMID: 22378730RESULT

  • 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.

    PMID: 21955650RESULT

  • 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.

    PMID: 32689933DERIVED

  • 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.

    PMID: 24065066DERIVED

MeSH Terms

Conditions

Diabetes, GestationalHyperglycemiaInsulin ResistanceObesityPregnancy in Obesity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Hanley, PhD

    University of Toronto

    STUDY CHAIR

  • Sylvia Ley, PhD

    University of Toronto

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 29, 2011

Study Start

March 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

CA(1)