Maternal Lipids and Offspring Adiposity at 5-7 Years (HAPO)

Maternal Lipids at 28 Weeks Gestation and Offspring Adiposity at Age 5-7 Years in the Hyperglycemia and Adverse Pregnancy Outcome Study

This study investigates the associations between measured maternal lipids (Total cholesterol, LDL-cholesterol , triglycerides and high-density lipoprotein cholesterol) at 28 weeks' gestation and offspring adiposity at 5-7 years. This was examined in a large observational study based in Belfast, UK.

Study Overview

• Status: Completed
• Conditions: Adiposity

Detailed Description

The concept of fuel mediated teratogenesis, as proposed by Freinkel in his 1980 Banting Lecture, postulated that altered fuel metabolism during pregnancy had a long lasting metabolic effect on the offspring. Although in the intervening years the focus has largely been on maternal glucose as the principal fetal fuel, animal studies have documented that other nutrients such as lipids can also be transferred across the placenta. Furthermore, the latter part of pregnancy is associated with a significant hyperlipidemia including hypercholesterolemia and hypertriglyceridemia. Although the relation of maternal lipids during pregnancy to birth outcomes is well documented, few studies have examined this relation to longer term outcomes. Such an association, if present, would lend further support to the presence of developmental programming in the offspring based on fuel mediated teratogenesis.

Against such a background, the aim of this study was to examine the association between maternal lipids during pregnancy and later offspring adiposity controlled for relevant confounders including maternal body mass index (BMI), gestational glycemia and offspring birth weight.

The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study was an international multicentre epidemiologic study that examined the associations of hyperglycemia during pregnancy to adverse maternal/fetal pregnancy outcomes. Eligible pregnant women attended the Royal Victoria Maternity Hospital for an oral glucose tolerance test between 24-32 weeks gestation to assess glucose tolerance. An additional fasting serum sample for analysis of lipids was taken.

The mothers and their offspring were invited to return to the study 5-7 years later. At this visit, offspring weight, height and skin fold thickness measurements were taken.

• Study Type: Observational
• Enrollment (Actual): 1224

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All pregnant women who attended the Royal Victoria Maternity Hospital were eligible to participate unless they met one or more of the exclusion criteria.

Description

Inclusion Criteria:

• In a pregnant state in the first/second trimester
• Attending the Royal Victoria Maternity Hospital

Exclusion Criteria:

• Age younger than 18 years
• A plan to undergo delivery at another hospital
• An uncertain date of last menstrual period and no ultrasonographic estimation between 6 and 24 weeks of gestational age
• Inability to complete the oral glucose-tolerance test within 32 weeks of gestation
• Multiple pregnancy
• Conception by means of gonadotropin ovulation induction or in vitro fertilization
• Glucose testing before recruitment or a diagnosis of diabetes during the current pregnancy
• Diagnosis of diabetes before the current pregnancy and requiring treatment with medication
• Participation in another study that could interfere with the HAPO study
• Infection with the human immunodeficiency virus or hepatitis B or C virus
• Previous participation in the HAPO study
• Inability to converse in the languages used on centre forms without the aid of an interpreter

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Belfast HAPO; All pregnant women who attended the Royal Victoria Maternity Hospital, Belfast were eligible to participate unless they met one or more exclusion criteria. All eligible women from the Belfast centre were invited to take part in a prospective observational study involving an additional fasting serum sample for lipids at 28 weeks gestation and long term follow up of their HAPO offspring. Only those women who had remained blinded to oral glucose tolerance test (OGTT) results during pregnancy were included (fasting plasma glucose ≤5·8 mmol/L and 2-hour glucose ≤11·1 mmol/L). Offspring from these pregnancies had anthropometric measurements performed within 72 hours of birth and at age 5-7 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI Z score	Adiposity expressed as body mass index (BMI) Z score	5-7 years
Sum of skin fold thicknesses	Sum of triceps, subscapular and suprailiac	5-7 years

Collaborators and Investigators

• Sponsor: Belfast Health and Social Care Trust
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Diabetes UK
• Investigators: Principal Investigator: David R McCance, MD, Belfast Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2001
• Primary Completion (ACTUAL): November 4, 2006
• Study Completion (ACTUAL): March 14, 2012

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2017
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy; teratogenesis
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: BelfastHSCT; R01HD034242 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No