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Completed

NCT Number: NCT03317522

Maternal Lipids and Offspring Adiposity at 5-7 Years

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. BMI Z score

    Time frame: 5-7 years

    Adiposity expressed as body mass index (BMI) Z score

  2. Sum of skin fold thicknesses

    Time frame: 5-7 years

    Sum of triceps, subscapular and suprailiac

Sponsors and collaborators

Lead sponsor

Belfast Health and Social Care Trust

Other

Collaborators

  • Diabetes UK
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: HAPO

Important dates

Study start
2001
Primary completion
2006
Study completion
2012
First posted
Oct 23, 2017
Registry last updated
Oct 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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