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Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

NCT ID: NCT01405547

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gestational Diabetes Hyperglycemia Insulin Resistance Obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pre-existing diabetes
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Diabetes Association

OTHER

Sponsor Role collaborator

Canadian Foundation for Dietetic Research (CFDR)

OTHER

Sponsor Role collaborator

Anthony Hanley

OTHER

Sponsor Role lead

Responsible Party

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Anthony Hanley

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anthony Hanley, PhD

Role: STUDY_CHAIR

University of Toronto

Sylvia Ley, PhD

Role: STUDY_DIRECTOR

University of Toronto

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 20925937 (View on PubMed)

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.

Reference Type RESULT
PMID: 22378730 (View on PubMed)

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.

Reference Type RESULT
PMID: 21955650 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32689933 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24065066 (View on PubMed)

Other Identifiers

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488057

Identifier Type: -

Identifier Source: org_study_id