Gestational Metabolic Abnormalities and Maternal and Infant Nutrition and Health

Obesity Clinical Trial

Official title:

Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405547
• Other study ID #: 488057
• Status: Completed
• Start date: March 2009
• Est. completion date: August 2012

Study information

• Verified date: November 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton or twin pregnancy

• aged 20 years or older at the time of recruitment

• intention to breastfeed

Exclusion Criteria:

• pre-existing diabetes

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Hyperglycemia
• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Anthony Hanley	Canadian Diabetes Association, Canadian Foundation for Dietetic Research (CFDR)

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant growth		Growth from birth to anthrometry at 12mo
Secondary	Human milk composition		At 3d and at 3mo postpartum
Secondary	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.	At 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7.
Secondary	Gestational diabetes		An expected average of 30 weeks of gestation
Secondary	Gestational metabolic abnormalities		An expected average of 30 weeks of gestation
Secondary	Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)		An expected average of 30 weeks of gestation