Clinical trial NCT01405547: Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health
Official title: Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Hyperglycemia
Insulin Resistance
Obesity
Keywords: Gestational Diabetes
Gestational Hyperglycemia
Gestational Insulinemia
Maternal Obesity
Human Milk
Lactogenesis
Obstetrics
Nutrition
Infant Growth
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
name: Canadian Foundation for Dietetic Research (CFDR)
First posted: 2011-07-29
Enrollment: 271
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Infant growth
timeFrame: Growth from birth to anthrometry at 12mo
Secondary outcomes:
measure: Human milk composition
timeFrame: At 3d and at 3mo postpartum
measure: Onset of lactogenesis II
timeFrame: At 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7.
measure: Gestational diabetes
timeFrame: An expected average of 30 weeks of gestation
measure: Gestational metabolic abnormalities
timeFrame: An expected average of 30 weeks of gestation
measure: Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)
timeFrame: An expected average of 30 weeks of gestation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anthony Hanley, PhD
role: STUDY_CHAIR
affiliation: University of Toronto
name: Sylvia Ley, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.